New in Oncology - July 3, 2025
Pump-Free Leukemia Win—and 66 new trials from PI3K to Pan-RAS
THIS WEEK’S BREAKTHROUGHS:
Pump-Free Blina Leads a Slim-but-Mighty Week
🏆 Subcutaneous blinatumomab, the CD19 BiTE, stole the spotlight, pushing complete-remission rates to 77% in hard-to-treat B-ALL—almost double the historical IV benchmark—while eliminating the hassle of a 28-day infusion pump.
Beyond this headline act, we logged five other signals: faster CDK4/6i failure in germline BRCA/PALB2 breast cancer, a brain-met vaccine pairing that shrank lesions in 5 of 6 patients, and more. See all the findings below.
And a sad, but important side note, Early alpha emitter fails to add benefit to prostate SABR for bone disease.
6 NEW FINDINGS
Breast Cancer (1), Breast Cancer: Brain Mets (1), Prostate Cancer (1), Kidney (Renal Cell) Carcinoma (1), ALL (1), AML (1)
THIS WEEK’S NEW TRIALS:
New Trials: Phase-3 EZH2 & PI3K, DLL3 ADC, and First-in-Human Pan-RAS Debut
A 66-trial avalanche hit this week—8 registrational gambits, 40 mid-stage proof of concepts, and 18 first-in-human shots on goal. From pathway-tuned endocrine combos to a pan-RAS frenzy, here are the eight studies that caught our eye.
🏆Phase III PI3K Pathway Upgrade: Inavolisib + letrozole + CDK4/6i aims to lift first-line outcomes for PIK3CA-mut HR+/HER2- mBC.
🏆EZH2 + AR Blockade Goes Registrational: Mevrometostat + enzalutamide targets metastatic castration-sensitive disease without adding chemo.
🏆 Chemo-Free Bispecific Triplet: Teclistamab + daratumumab + talquetamab tests a frontline, high-risk NDMM regimen built entirely on immune engager
🏆DLL3-Targeted ADC Expansion: ZL-1310 moves forward after early topoisomerase-payload responses in platinum-pretreated NEC.
🏆 Pan-RAS Inhibitor ERAS-0015 Enters Clinic: First-ever FIH study tackles RAS-mutant cancers across histologies.
🏆 PRMT5 + KRAS Combo (TNG462) Launches: Simultaneous MTAP-loss and RAS targeting seeks synthetic-lethal efficacy in PDAC and NSCLC.
🏆 KRAS-G12D Degrader ARV-806 Debuts: First degrader for the common G12D allele opens in pancreatic and other solid tumors.
🏆Biomarker-Guided Ruxolitinib: Pre-emptive JAK1 inhibition takes a fresh swing at preventing chronic GVHD post-allo-HCT.
And that’s just the surface—scroll for all 66 trial details.
66 NEW TRIALS
Breast Cancer (6), NSCLC (1), SCLC (1), Thyroid Carcinoma (1), Ovarian Cancer (1), Cervical Cancer (2), Prostate Cancer (5), Bladder Cancer (2), HCC (1), Upper GI Cancer (1), Colorectal Cancer (1), Head and Neck Cancer (1), Glioma (1), Neuroendocrine Tumor (5), Multiple Myeloma (3), Hodgkin Lymphoma (2), DLBCL (2), Anaplastic Large Cell Lymphoma (2), CLL/SLL (2), AML (3), Other Solid Tumors (20), Hematological Cancer (3)
6 New Findings This Week
Breast Cancer
BRCA/PALB2 Mutations Cut Real-World PFS to 11 mo on First-Line CDK4/6i in HR+/HER2− mBC
Using France’s ESME registry, investigators retrospectively analyzed 4820 women with HR+/HER2− metastatic breast cancer who initiated first-line CDK4/6 inhibition plus endocrine therapy between 2013-2023 (palbociclib 74%, ribociclib 17%, abemaciclib 13%). Median PFS was 11.2 m for the 90 patients harboring pathogenic BRCA1/2 or PALB2 variants versus 15.7 m in 523 tested wild-type and 18.9 m in 4207 untested patients (adjusted HR 1.48, p = 0.003); OS was ~50 m in both mutation-positive and wild-type groups. By contrast, pivotal randomized trials of palbociclib (PALOMA-2) and abemaciclib (MONARCH 3) report PFS 24.8 m and 29 m, respectively, in unselected HR+/HER2− disease, highlighting a sizeable efficacy gap for germline DDR-mutated tumors.
Take Home: These data suggest BRCA/PALB2-mutated patients progress faster on CDK4/6 + ET, bolstering ongoing first-line PARP-inhibitor trials, but the small (n = 90) retrospective cohort means practice should await prospective confirmation. It’s too bad not every patient gets tumor sequencing!
Breast Cancer: Brain Mets
Bria-IMT Vaccine + Pembrolizumab Shrinks Brain Mets in 5 of 6 Patients; Tumor-Agnostic Basket Trial Launches
Bria-IMT—an irradiated, GM-CSF–secreting allogeneic breast-cancer cell line (SV-BR-1-GM) that functions as an antigen-presenting vaccine—is moving into the single-site ASTRO-VAC CNS phase 1 basket (NCT06072612) after earlier phase 1/2 work showed intracranial lesion reductions in 5/6 evaluable metastatic-breast-cancer patients (median −60%, range −42% to −100%) and 40% disease control post-ADC therapy, with manageable safety. The new study pairs Bria-IMT with pembrolizumab for solid-tumor brain-met patients progressing after standard care; key read-outs will be intracranial disease-control and radiographic PFS.
Take Home: Encouraging 83% early breast cancer brain-met control justifies this basket approach, but with only six prior patients the vaccine still needs to prove durability and activity before it can claim a CNS niche.
Prostate Cancer
6-mo Triple AR Blockade + Metastasis-Directed RT Yields 83% Deep PSA Response in Synchronous PSMA-PET Oligometastatic Prostate Cancer
In a pooled post-hoc look at the Phase 2 SOLAR (NCT03298087) and SATURN (NCT03902951) trials, 50 PSMA-PET-defined castrate-sensitive oligometastatic patients (≤5 lesions) received 6 months of leuprolide, abiraterone + prednisone, and apalutamide plus stereotactic body RT to all mets; synchronous cases (treatment-naïve) also had prostate surgery or definitive RT. Synchronous disease showed 83% “deep” PSA response (<0.05 ng/ml or <2 ng/ml post-RT) versus 50% in metachronous recurrences (p = 0.018) and enjoyed significantly longer progression-free and eugonadal PFS (p < 0.05), while prior ADT predicted resistance. For perspective, standard AAP + ADT in high-risk metastatic CSPC drives PSA ≤ 0.1 ng/ml at 6 months in ~40% of men, and the ARASENS triplet (darolutamide + ADT + docetaxel) reaches ~67% undetectable PSA, positioning this finite multimodal regimen at the top of the response curve with only half a year of systemic therapy.
Take Home: If larger studies replicate the durability, a six-month “androgen annihilation + SBRT” package could spare newly diagnosed oligometastatic patients years of continuous ARSI while delivering deeper biochemical remissions—but head-to-head data against triplet standards are still needed.
https://pubmed.ncbi.nlm.nih.gov/40541485
Kidney (Renal Cell) Carcinoma
VEGF-Blocker Bevacizumab + EGFR-TKI Erlotinib Delivers 72% ORR and 21-mo mPFS in Hereditary Papillary RCC
Bevacizumab (anti-VEGF antibody) plus erlotinib (EGFR tyrosine-kinase inhibitor) was tested in an open-label Phase 2 study (NCT01130519) enrolling 43 patients with fumarate-hydratase–mutated hereditary leiomyomatosis and renal-cell cancer (HLRCC)-associated papillary RCC and 40 with sporadic papillary RCC. Confirmed responses were seen in 72% of hereditary cases and 35% of sporadic cases; mPFS was 21.1 mo and 8.9 mo, respectively, with mOS 44.6 mo vs 18.2 mo. Grade ≥3 toxicity included hypertension (34%) and proteinuria (17%), alongside mostly low-grade acneiform rash (93%) and diarrhea (89%). For context, the current cabozantinib reference standard in metastatic papillary RCC shows 23% ORR and 9 mo mPFS in the SWOG S1500 trial, underscoring the doublet’s outsized activity—particularly in HLRCC, where no approved therapy exists.
Take Home: If validated, this oral–IV VEGF/EGFR combo could become the first regimen to offer durable control for FH-mutated papillary RCC, eclipsing MET-targeted TKIs and highlighting the need for germline testing in rare kidney cancer subsets.
https://pubmed.ncbi.nlm.nih.gov/40532152
Acute Lymphoblastic Leukemia (ALL)
🏆 SPOTLIGHT: Convenience + high remission rate = great outcomeSubcutaneous Blinatumomab Achieves 77% CR in Relapsed/Refractory B-ALL, Surpassing IV Benchmarks
Blinatumomab, a CD19×CD3 bispecific T-cell engager, was reformulated for subcutaneous (SC) delivery and evaluated in the phase 1/2 NCT04521231 study across 88 adults with relapsed/refractory B-cell ALL. Once-daily 250 µg (week 1) then 500 µg thrice-weekly, or 500 µg→1000 µg schedules produced complete remission/CRh in 75% and 79% of patients, respectively (overall 77%), after a median 5-month follow-up. Grade 3-4 toxicities were neutropenia 22%, cytokine-release syndrome 20%, and ICANS 17%; no treatment-related deaths occurred. By comparison, intravenous blinatumomab in the TOWER trial achieved 44% CR/CRh and median OS 7.7 months, while salvage chemotherapy historically yields 18-44% remissions, underscoring the SC regimen’s higher early response without continuous infusion pumps
Take Home: If sustained, these high remission rates paired with outpatient-friendly dosing could shift blinatumomab to a more convenient standard for R/R ALL, provided long-term durability and neuro-/cytokine-toxicity profiles remain manageable.
https://pubmed.ncbi.nlm.nih.gov/40532723
Acute Myeloid Leukemia (AML)
Ven-CLAG-M Nabs 65% CR in Adverse-Risk or Relapsed AML
Venetoclax, a BCL-2 inhibitor, was layered onto the intensive CLAG-M backbone (cladribine 5 mg/m² ×5 days, cytarabine 1.5 g/m² ×5, mitoxantrone 16/18 mg/m² ×3, plus G-CSF priming) in a first-in-human Phase 1 dose-escalation trial (NCT04797767). Twenty fit adults with newly diagnosed adverse-risk or relapsed/refractory AML/high-grade myeloid neoplasms received venetoclax 400 mg once-daily on days 1-14. Composite complete remission (CR + CRi) reached 65% with measurable-residual-disease negativity in many responders; 28-day mortality was 5%. Dose-limiting toxicities included grade 4 respiratory failure and sepsis, but the regimen’s early death rate mirrored historical CLAG-M (≈6-7%) while lifting CR from ~52-60% to 65%
Take Home: A modest bump in remission—and no extra early deaths—makes Ven-CLAG-M a credible next-gen induction to test in a Phase 2 setting, but the tiny n and short follow-up mean we still need proof it bests 7+3 or CLAG-M in durable survival.
https://pubmed.ncbi.nlm.nih.gov/40535475
66 New Trials This Week
🆕 18 First-in-human
🔄 40 Expansion
✅ 8 RegistrationalBreast Cancer Trials
🏆 SPOTLIGHT: New phase III for HR+ PI3K-mutated BC✅ Phase 3 Inavolisib PI3K inhibitor trial in advanced breast cancer
This multicenter study by Hoffmann-La Roche compares inavolisib plus letrozole and a CDK4/6 inhibitor versus placebo with the same backbone in patients with PIK3CA-mutated, hormone receptor–positive, HER2–negative advanced breast cancer. The trial is designed to evaluate improved first-line treatment strategies.
42 Locations | NCT06790693
🔄 Phase II Ivonescimab, a PD-1/VEGF bispecific antibody trial
This single arm study evaluates ivonescimab added to carboplatin and docetaxel administered every 3 weeks for 6 cycles as neoadjuvant therapy in early-stage triple negative breast cancer. Sponsored by Cedars-Sinai Medical Center, it assesses safety, pathological responses at surgery, and long-term outcomes with integrated imaging and biomarker analyses.
3 Locations | NCT07017673
🔄 Phase 2 Mayo Ultrasound Marker: Enhancing lymph node imaging via twinkling artifact
This trial evaluates the safety and ultrasound performance of an optimized marker in women with biopsy-confirmed, node-positive breast cancer. Using ultrasound-guided placement followed by imaging and surgical resection, the study aims to improve consistent marker visibility and surgical planning, addressing a key challenge in breast cancer management at Mayo Clinic.
🔄 Phase I/II Trial: Naxitamab (GD2 mAb) + Sacituzumab Govitecan (TROP2-directed ADC)
This study evaluates safety, dosing, and efficacy of the combination in metastatic triple-negative breast cancer patients eligible for second-line or later treatment. Conducted by MD Anderson in Houston, the trial explores a novel regimen using both GD2- and TROP2-targeted therapies.
🔄 Phase II trial of darolutamide, an androgen receptor inhibitor, in early-stage AR+ TNBC
This study compares neoadjuvant standard chemotherapy plus immunotherapy with versus without darolutamide in stage II-IIIA AR+ triple-negative breast cancer at Nashville, sponsored by Vandana Abramson. It evaluates whether adding darolutamide can enhance tumor shrinkage before surgery.
✅ Phase 2/3 trial of Izalontamab Brengitecan, EGFR/HER3 bispecific ADC with topoisomerase inhibition
This randomized, open-label study compares iza-bren monotherapy versus physician’s choice in first-line metastatic triple-negative or ER-low, HER2-negative breast cancer patients ineligible for anti-PD(L)1 or endocrine therapies. Sponsored by Bristol-Myers Squibb, the trial evaluates safety and efficacy of a bispecific ADC targeting EGFR and HER3 with a topoisomerase inhibitor payload.
192 Locations | NCT06926868
NSCLC Trial
🔄 Phase II GT103 mAb targeting complement factor H with pembrolizumab for STK11 NSCLC
This study tests GT103 with pembrolizumab as a combination immunotherapy for advanced STK11 mutant non‐small cell lung cancer. Sponsored by Roswell Park Cancer Institute, the trial evaluates GT103’s novel complement factor H targeting in a Phase II setting to potentially improve outcomes.
SCLC Trial
🔄 Phase 2 trial of BMS-986489, atigotatug (anti-fucosyl-GM1 monoclonal antibody) plus PD-1 inhibitor, in SCLC consolidation
An open-label randomized study compares the fixed-dose combination of atigotatug and nivolumab (BMS-986489) with standard durvalumab consolidation following chemoradiotherapy in limited-stage small-cell lung cancer. Sponsored by SCRI Development Innovations, LLC, the trial evaluates efficacy and safety in approximately 250 participants, exploring a novel immunotherapy approach.
21 Locations | NCT06773910
Thyroid Carcinoma Trial
🔄 Phase 1/2 trial of 177Lu-DOTA-EB-TATE, somatostatin receptor directed beta emitter
This open-label study tests a three-dose regimen of 177Lu-DOTA-EB-TATE to assess safety, dosimetry, and efficacy in adults with metastatic, radioactive iodine non-responsive Hurthle cell thyroid cancer. Sponsored by NIDDK in Bethesda, the trial evaluates a targeted radiopharmaceutical approach for a rare cancer with limited treatment options.
Ovarian Cancer Trial
✅ Phase III Olaparib PARP Inhibitor Maintenance in Ovarian Cancer
This phase III trial compares one versus two years of maintenance olaparib—with or without bevacizumab—in patients with BRCA1/2-mutated or HRD+ stage III-IV ovarian cancer following first-line platinum-based chemotherapy. NRG Oncology is evaluating the optimal olaparib duration to delay disease progression.
342 Locations | NCT06580314
Cervical Cancer Trials
🔄 Phase 4 TIVDAK tissue factor–directed antibody-drug conjugate ocular safety trial
This study by Pfizer evaluates ocular side effects in patients with recurrent/metastatic cervical cancer post-chemotherapy. Eligible participants have no active eye issues and are TIVDAK-naïve, with scheduled eye exams before treatment, during, and after every three-week infusion.
3 Locations | NCT06952660
🔄 Phase II Investigational HDR Brachytherapy (dose-adjusted internal radiotherapy) in cervical cancer.
This prospective non-randomized trial from Stanford University in Palo Alto evaluates a 3-fraction versus standard 4-fraction HDR brachytherapy regimen in locally advanced cervical cancer. Patients meeting dosimetric criteria receive the investigational treatment, aiming to personalize therapy and improve treatment efficiency.
Prostate Cancer Trials
🏆 SPOTLIGHT: Next-gen EZH2 inhibitor + AR Blockade Heads to Phase 3✅ Phase 3 trial of Mevrometostat, an EZH2 inhibitor, with Enzalutamide in metastatic castration-sensitive prostate cancer
This randomized trial evaluates whether combining investigational Mevrometostat with enzalutamide improves outcomes for ARPI-naïve, chemo-naïve metastatic castration-sensitive prostate cancer patients compared to enzalutamide alone. Sponsored by Pfizer, the study examines a novel approach integrating an EZH2 inhibitor with an established androgen receptor blocker.
8 Locations | NCT07028853
🔄 Phase 1b 177Lu-PSMA-617, PSMA directed beta emitter for mCRPC
This single-arm study at MD Anderson evaluates Lu-PSMA-617, administered IV every six weeks, for men with metastatic castration-resistant prostate cancer, PSA rise, bone marrow involvement, and cytopenia after second-line therapy. The trial focuses on determining safety and preliminary efficacy in this challenging population.
✅ Phase 3 64Cu-SAR-bisPSMA PSMA-targeted imaging agent for recurrent prostate cancer
This study evaluates 64Cu-SAR-bisPSMA PET/CT for detecting prostate cancer recurrence in patients with prior prostatectomy, radiation, cryotherapy, or brachytherapy. Sponsored by Clarity Pharmaceuticals in Omaha, it is a Phase 3 trial assessing a PSMA-directed imaging agent for biochemical recurrence.
🔄 Phase II: Darolutamide, Androgen Receptor Inhibitor in Prostate Cancer Neoadjuvant Study
This single-arm phase II trial by Icahn School of Medicine at Mount Sinai evaluates neoadjuvant ADT with leuprolide, darolutamide, and pembrolizumab followed by adjuvant pembrolizumab in NCCN high-risk non-metastatic prostate cancer patients identified by the Decipher assay.
🔄 Phase 2 trial of relugolix, a GnRH receptor inhibitor improving PSMA PET/CT sensitivity.
This Phase 2 randomized study by Mayo Clinic evaluates short-course relugolix (administered for 5, 10, or 15 days) to boost PSMA expression and enhance PET/CT imaging in high/very high risk prostate cancer patients scheduled for robotic radical prostatectomy.
Bladder Cancer Trials
🔄 Phase 2 TYRA-300 FGFR3-directed mAb trial
This open-label study at Nashville evaluates TYRA-300 monotherapy in patients with FGFR3-altered, low grade, intermediate risk non-muscle invasive bladder cancer. The trial features dose-finding cohorts sponsored by Tyra Biosciences, offering early insights into targeted treatment for NMIBC.
🔄 Phase 2 study V940 personalized mRNA vaccine for patient-specific cancer immune targeting
This Phase 2 study evaluates whether combining V940 with standard BCG extends event-free survival compared to BCG alone, as well as the efficacy of V940 monotherapy in high-risk non-muscle invasive bladder cancer. Conducted at sites such as Madrid, New York, and Los Alamitos with Merck Sharp & Dohme LLC sponsoring, the trial explores a novel personalized mRNA immunotherapy approach in a first-in-patient setting.
22 Locations | NCT06833073
Primary Hepatocellular Carcinoma (HCC) Trial
🔄 Phase 1 trial: Tremelimumab, CTLA-4 directed mAb combined with radiotherapy for HCC
This Phase 1 study tests a preoperative protocol combining three fractions of focused radiotherapy with one dose of Tremelimumab followed by Durvalumab every four weeks, in patients with resectable or advanced hepatocellular carcinoma. Sponsored by Weill Medical College of Cornell University, the trial examines the safety and potential efficacy of this novel immunoradiotherapy approach.
Upper GI Cancer Trials
🆕 Phase 1 vvDD-hIL2: Oncolytic vaccinia virus with IL2 expression
This Phase 1 study evaluates vvDD-hIL2 administered via intra-tumoral injection to determine optimal dose and safety in patients with metastatic gastrointestinal and peritoneal tumors (MSI-H and MSS) at AHN West Penn Hospital. The trial advances oncolytic immunotherapy using a genetically modified vaccinia virus expressing IL2 in a three-dose escalation design at Allegheny Singer Research Institute.
Colorectal Cancer Trial
🔄 Phase 2 trial: BMS-986340, a CCR8-targeting antibody, in advanced microsatellite-stable colorectal cancer
The study evaluates a single‐arm regimen combining BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab for patients with advanced or metastatic refractory microsatellite-stable colorectal cancer. Conducted by M.D. Anderson Cancer Center, it explores a novel CCR8-directed approach in a challenging treatment setting.
Head and Neck Cancer Trial
🔄 Phase II Pilot: SCRT – hypofractionated radiation for high-risk cSCC local control
This Phase II trial evaluates whether five-fraction SCRT offers effective local control for adults with head and neck cutaneous squamous cell carcinoma and if active surveillance is a safe alternative in moderate-risk patients. Sponsored by University of Vermont Medical Center, the study compares treatment outcomes against historical data to inform future adjuvant therapy approaches.
Glioma Trial
🔄 Phase 1 trial: Dasatinib tyrosine kinase inhibitor for residual glioma
This Phase 1 trial led by Mayo Clinic in Rochester evaluates safety, tolerability, and potential efficacy of sequential combination regimens – starting with dasatinib plus quercetin, fisetin, and temozolomide – in previously treated glioma patients with residual disease (including those with IDH mutations or MGMT methylation) using imaging and biospecimen assessments to guide individualized treatment strategies.
Neuroendocrine Tumor Trials
🏆 SPOTLIGHT: A new DLL3 ADC🔄 Phase Ib/II ZL-1310: DLL3-targeted Topoisomerase I inhibitor in selected solid tumors.
This multi-center, open-label trial from Zai Lab (Shanghai) is assessing ZL-1310 as a single-agent therapy in patients with neuroendocrine carcinomas progressing after platinum therapy. The study is conducted at sites in the US and China to evaluate safety and preliminary efficacy.
8 Locations | NCT06885281
🔄 Phase 1 study of naxitamab GD2-directed monoclonal antibody in neuroblastoma
This trial uses a modified 3+3 design to assess the optimal naxitamab infusion duration with irinotecan, temozolomide, and sargramostim in patients with relapsed or refractory neuroblastoma or ganglioneuroblastoma. It explores whether slower naxitamab infusions can reduce treatment-related toxicities.
🔄 Phase 2/3 Zanzalintinib Trial: cMet/VEGFR inhibitor in Neuroendocrine Tumors
This multicenter, randomized open-label study sponsored by Exelixis compares daily oral zanzalintinib to everolimus in patients with previously treated, unresectable locally advanced or metastatic neuroendocrine tumors (Grade 1-3) of pancreatic or extra-pancreatic origin. The trial explores the effectiveness of a cMet/VEGFR inhibitor in a progressing population.
🆕 Phase 1 trial of PHOX2B PC-CAR T, a PHOX2B-directed CAR-T therapy
This first-in-human dose escalation trial uses a standard 3+3 design to determine the maximum tolerated dose in patients with relapsed or refractory high‐risk neuroblastoma. The study, led by Stephan Grupp MD PhD in Philadelphia, aims to assess safety and preliminary tumor response.
✅ Phase 3 trial of [177Lu]Lu-DOTA-TATE, a somatostatin receptor-targeted radioligand therapy.
This study evaluates the efficacy and safety of [177Lu]Lu-DOTA-TATE plus octreotide LAR versus octreotide LAR alone as first-line treatment in newly diagnosed patients with well-differentiated, somatostatin receptor positive advanced gastroenteropancreatic NETs (Grade 1-2). Conducted in Fayetteville under Novartis oversight, the trial employs a randomized, open-label design to compare combination versus standard therapy.
Multiple Myeloma Trials
🏆 SPOTLIGHT: A New Frontline Treatment for High-Risk Myeloma🔄 Phase 2 teclistamab bispecific BCMA/CD3 antibody trial in high-risk multiple myeloma
This open-label Phase 2 trial investigates sequencing of teclistamab, daratumumab, and talquetamab—with or without melphalan transplant—for newly diagnosed high-risk multiple myeloma patients stratified by minimal residual disease status. The study enrolls 1st or 2nd line patients at Little Rock under University of Arkansas oversight, exploring innovative bispecific antibody combinations for improved disease control.
🔄 Phase 2 linvoseltamab: BCMA and CD3 bispecific antibody
This phase 2 study evaluates the safety and efficacy of linvoseltamab in multiple myeloma patients relapsed after BCMA CAR T-cell therapy. All subjects receive an initial inpatient step-up dosing regimen followed by weekly, biweekly, and monthly infusions in a single-center trial at the Medical College of Wisconsin in Milwaukee.
🔄 Phase 1/2 Belantamab Mafodotin, a BCMA-targeted tubulin inhibitor ADC study
This trial evaluates escalating doses of belantamab alone or combined with belantamab mafodotin for relapsed/refractory multiple myeloma patients (≥4 prior therapies). Sponsored by GlaxoSmithKline, the multicentre study spans sites in Asia, Europe, and the Americas to define optimal dosing for this targeted therapy.
20 Locations | NCT05714839
Hodgkin Lymphoma Trials
🔄 Phase 2 pembrolizumab PD-1 inhibitor with GVD consolidation in relapsed/refractory Hodgkin lymphoma
This Phase 2, open-label study evaluates pembrolizumab plus GVD consolidation in relapsed or refractory classic Hodgkin lymphoma patients with prior doxorubicin use. FDG-PET/CT imaging and Foresight CLARITY liquid biopsy for ctDNA detection guide consolidation decisions across multiple University of California sites.
6 Locations | NCT07021989
🔄 Phase 2 Brentuximab Vedotin ADC, a CD30-targeted tubulin inhibitor.
This trial at the University of Miami evaluates the efficacy and safety of the abbreviated BrECADD regimen in patients with Stage 2B-4 Hodgkin Lymphoma. An exploratory objective is to assess circulating tumor DNA as a biomarker for minimal residual disease over a 24‑month period.
Diffuse Large B-Cell Lymphoma Trials
🔄 Phase 1b glofitamab CD20/CD3 bispecific mAb for frontline DLBCL in older adults
This study evaluates a combination treatment using glofitamab with polatuzumab, obinutuzumab, and R-miniCHP for untreated patients (65+) with DLBCL, HGBCL, or transformed lymphoma. A response-adapted design based on interim PET scans supports tailored therapy in an investigational trial sponsored by Memorial Sloan Kettering Cancer Center.
7 Locations | NCT06765317
🔄 Phase Ib Loncastuximab Tesirine (anti-CD19 ADC) and Roflumilast (PDE4 inhibitor) in High-Risk DLBCL
This Phase Ib single-arm trial evaluates a combination of Loncastuximab Tesirine, Roflumilast, and standard R-CHOP in newly diagnosed high-risk diffuse large B-cell lymphoma. The study, led by The University of Texas Health Science Center at San Antonio, will assess safety, tolerability, and tumor response.
Anaplastic Large Cell Lymphoma Trials
🔄 Phase I alectinib (ALK kinase inhibitor) plus duvelisib (PI3K delta-gamma inhibitor) dual-target trial
This study evaluates the safety and efficacy of alectinib lead-in followed by duvelisib combination to establish tolerable doses in relapsed/refractory ALK+ anaplastic large cell lymphoma. Conducted by Memorial Sloan Kettering and New York sites, it explores dose escalation and treatment durability in a second-line plus setting.
7 Locations | NCT07001384
🔄 Phase 2 Nivolumab Checkpoint Blockade in Relapsed/Refractory ALK+ ALCL
This trial evaluates risk-adapted chemommunotherapy—with Nivolumab and tailored chemotherapy potentially followed by an allogeneic stem cell transplant—in children, adolescents, and young adults with relapsed/refractory ALK+ anaplastic large cell lymphoma. Sponsored by New York Medical College, it aims to improve survival outcomes using this novel immune-based approach.
CLL & SLL Trials
🔄 Phase 2 LP-168 small molecule inhibitor and obinutuzumab CD20 mAb in CLL/SLL.
This multicenter parallel 2-cohort trial evaluates LP-168 with obinutuzumab in previously treated CLL/SLL patients, including those with a BTK gatekeeper T474 mutation. The study aims to assess safety and preliminary efficacy in a population with limited treatment options in Cincinnati, sponsored by Zulfa Omer.
✅ Phase 3 Study: Sonrotoclax, BCL2 Inhibitor, with Anti-CD20 Therapies in R/R CLL/SLL.
This trial compares sonrotoclax combined with anti-CD20 antibodies to standard venetoclax plus rituximab in adults with relapsed/refractory CLL/SLL receiving second-line or later therapy. Conducted at multiple international sites and sponsored by BeiGene, the study evaluates safety and efficacy across four treatment arms, including an MRD-guided approach.
138 Locations | NCT06943872
Acute Myeloid Leukemia Trials
🆕 Phase 1 Trial of miRisten, a cell growth molecule blocker, for relapsed/refractory AML
This Phase 1 trial at City of Hope Medical Center evaluates miRisten administered via IV infusion on a multi-day schedule to determine its safety, tolerability, and optimal dosing in adult patients with relapsed/refractory AML. Detailed cardiac assessments and biomarker sampling aim to clarify its mechanism and clinical potential.
🔄 Phase 1 trial of atezolizumab PD-L1 mAb combined with CIML natural killer cells in AML.
This study aims to determine the maximum tolerated dose of cytokine-induced memory-like NK cells with atezolizumab and IL-2 in relapsed/refractory acute myelogenous leukemia. Participants have various genetic AML subtypes lacking standard care options. Memorial Sloan Kettering leads the trial employing standard lymphodepleting chemotherapy to assess safety and preliminary efficacy.
7 Locations | NCT07011004
🔄 Phase 1b dexamethasone (glucocorticoid) plus venetoclax trial in treatment-naïve AML.
This investigator-initiated single-arm study at the University of Vermont evaluates the safety and tolerability of adding dexamethasone to venetoclax-based low-intensity therapy in adult AML patients ineligible for intensive chemotherapy, with up to six 28-day cycles and assessments of patient-reported outcomes and early treatment responses.
Other Solid Tumors Trials
🏆 SPOTLIGHT: A New Pan-RAS Inhibitor Enters the Clinic🆕 Phase 1 study of ERAS-0015, a RAS inhibitor small molecule.
This open-label study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of ERAS-0015 administered alone or with additional investigational agents in patients with advanced or metastatic solid tumors harboring RAS mutations. Enrolling patients at Fairfax and sponsored by Erasca, Inc., the study aims to optimize dosing in this first-in-human trial.
🏆 SPOTLIGHT: Interesting Combo! PRMT5 + KRAS🆕 Phase 1/2 TNG462 PRMT5 inhibitor trial with KRAS inhibitor combinations.
This open-label, multicenter trial evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of oral TNG462 combined with investigational KRAS agents RMC-6236 or RMC-9805 in patients with pancreatic or non-small cell lung cancer exhibiting MTAP loss and RAS mutation. Conducted in Irving and Fairfax, the study is sponsored by Tango Therapeutics.
2 Locations | NCT06922591
🏆 SPOTLIGHT: A New KRAS G12D Inhibitor!🆕 Phase 1/2 trial ARV-806 KRAS (G12D) inhibitor in advanced cancer.
This open-label Phase 1/2 study evaluates ARV-806 administered via IV infusion in adults with advanced KRAS G12D-mutated tumors, including metastatic pancreatic ductal adenocarcinoma. Sponsored by Arvinas Inc. and conducted in Fairfax, the trial seeks to determine optimal dosing and assess early anti-tumor activity in a first-in-human setting.
🔄 Phase 1/2 Patritumab Deruxtecan, HER3-directed Topoisomerase I Inhibitor ADC
The study evaluates safety, PK, and efficacy of patritumab deruxtecan as monotherapy in children with relapsed or refractory hepatoblastoma or rhabdomyosarcoma, given via IV every 3 weeks. The trial, conducted by Merck Sharp & Dohme in Iowa City and Seoul, explores a novel HER3-directed antibody-drug conjugate in pediatric oncology.
2 Locations | NCT06941272
🔄 Phase I/II trial: DT2216, a BCL‑xL degrader, combined with irinotecan for refractory pediatric cancers
This phase I/II trial by the Children’s Oncology Group evaluates the safety, tolerability, and preliminary efficacy of DT2216 with irinotecan in children, adolescents, and young adults with relapsed or refractory solid tumors and fibrolamellar carcinoma (with DNAJB1:PRKACA fusion). The study explores a first-in-human combination aimed at targeting tumor cell survival.
3 Locations | NCT06620302
🔄 Phase 1b/2 Evorpacept trial: CD47-binding Ig Fc fusion protein in oncology.
This study evaluates evorpacept in combination with anti-cancer therapies in advanced and metastatic tumors. The trial enrolls patients with HER2+ breast, colorectal, and head and neck cancers in both randomized and dose-escalation cohorts. Sponsored by ALX Oncology across multiple centers, it aims to define the safety and preliminary efficacy of this first-in-human combination approach.
🆕 Phase 1 AB821 trial of CD8-targeted IL-21 immunotherapy.
This open-label, dose-escalation study at Yale University in New Haven evaluates AB821 monotherapy given every 2 weeks in adults with recurrent, locally advanced or metastatic melanoma and other immune-responsive solid tumors, including NSCLC. It is a first-in-human trial assessing safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity.
🆕 Phase 1b [225Ac]Ac-AKY-1189 Nectin-4 Radiopharmaceutical, a Nectin-4-directed alpha emitter.
This first-in-human, two-part study led by Aktis Oncology evaluates the safety and maximum tolerated dose of [225Ac]Ac-AKY-1189 monotherapy in patients with advanced or metastatic solid tumors. Conducted at Grand Rapids, the trial explores a novel radioimmunotherapy for previously treated disease.
🆕 Phase 1 Study of BL-M17D1: HER2-directed mAb Auristatin (tubulin inhibitor) ADC
This Phase 1 open-label trial, sponsored by SystImmune Inc., assesses BL-M17D1 administered every three weeks in patients with HER2-expressing or HER2-mutated advanced/metastatic solid tumors. The study includes cohorts from urothelial, NSCLC, gastric, and gynecologic cancers to evaluate safety, tolerability, pharmacokinetics, and efficacy as monotherapy with dose escalation, dose finding, and expansion strategies.
12 Locations | NCT06714617
🆕 Phase 1/2 trial of CGT4859, an FGFR2/3 inhibitor, in advanced solid tumors
This open-label study evaluates the safety, dosing, and antitumor activity of oral CGT4859 administered via dose escalation and expansion in adults with unresectable or metastatic intrahepatic cholangiocarcinoma and advanced solid tumors harboring FGFR2/3 alterations. Sponsor Cogent Biosciences conducts the trial across multiple US sites.
10 Locations | NCT06777316
✅ Phase III RT Trial: VLDRT as ionizing radiation for DNA damage in indolent lymphomas
Memorial Sloan Kettering Cancer Center is investigating whether very low dose radiotherapy (4 Gy in 1-2 fractions) is as effective as standard treatment (24 Gy in 12 fractions) for untreated indolent B-cell lymphomas including follicular, marginal zone, and MALT lymphomas. This randomized Phase III study evaluates tumor control and side effect profiles using PET-guided response assessment.
7 Locations | NCT07029217
🆕 Phase 1/2 trial of AVZO-023, a CDK4/CDK6 inhibitor.
This trial by Avenzo Therapeutics assesses AVZO-023 safety and antitumor activity as monotherapy and in combination with AVZO-021, fulvestrant, or letrozole in patients with advanced solid tumors including HR+/HER2- metastatic breast cancer, marking the first clinical investigation of this agent.
8 Locations | NCT06998407
🆕 Phase 1 VIR-5525 EGFR-directed T-cell engager trial.
This first-in-human study evaluates VIR-5525 as monotherapy and with pembrolizumab in dose-escalation and expansion cohorts for locally advanced or metastatic solid tumors expressing EGFR, including HNSCC, CRC, and NSCLC/CSCC. Sponsored by Vir Biotechnology, Inc., the trial assesses safety, pharmacokinetics, and preliminary anti-tumor activity.
3 Locations | NCT06960395
🆕 Phase 1 study of NKT5097, a CDK2/CDK4/6 inhibitor for advanced solid tumors.
This open-label study evaluates the safety, tolerability, and pharmacokinetics of NKT5097 in adults with advanced/metastatic solid tumors, including breast cancer and CCNE1-amplified cases. The trial features dose escalation and expansion to determine the recommended dose and assess preliminary anti-tumor activity, sponsored by NiKang Therapeutics at multiple U.S. sites.
4 Locations | NCT07029399
🆕 Phase 1 trial of [Ga-68]MTP220, targeted PET tracer.
This first-in-human, single-arm open-label study evaluates the safety and imaging efficacy of a one-time injection of [Ga-68]MTP220 followed by serial PET/CT scans during a 2.5-hour session. It enrolls newly diagnosed head and neck and pancreatic cancer patients at a Cleveland site, supported by sponsor Qiubai Li.
🔄 Phase 1 Tirbanibulin Ointment DNA synthesis inhibitor trial for keratinocyte carcinomas
This trial evaluates fractional laser therapy alone versus in combination with tirbanibulin ointment for treating squamous and basal cell carcinomas. Eligible first-line patients with superficial to invasive keratinocyte carcinomas are enrolled to assess if the combined approach can minimize invasive surgery and improve cosmetic outcomes at a New York site sponsored by Bruce Robinson, MD.
🆕 Phase 1/2a VS-7375 trial: KRAS G12D inhibitor for advanced solid tumors
This open-label study evaluates VS-7375 alone or with cetuximab in patients with advanced metastatic solid tumors harboring KRAS G12D mutations, including pancreatic, lung, and colorectal cancers. The trial aims to determine the optimal dosing and assess preliminary safety and efficacy, and is conducted at sites in Nashville, Houston, and Seattle by Verastem, Inc.
3 Locations | NCT07020221
🆕 Phase 1 PF-08046031 anti-CD228 ADC trial for advanced melanoma and solid tumors.
This open-label Phase 1 study evaluates PF-08046031 as monotherapy in adults with metastatic melanoma and other advanced solid tumors lacking approved treatment options. The trial, conducted by Pfizer at sites including Denver, Santa Monica, Orlando, and Los Angeles, aims to determine safety, dosing, and early signs of anti-tumor activity.
4 Locations | NCT06799533
🆕 Phase 1 ARC101 CLDN6-directed T-cell receptor engager trial in advanced cancers.
A first-in-human trial assessing escalating doses and expansion cohorts of ARC101 as monotherapy in patients with advanced or metastatic solid tumors, including testicular and ovarian cancers expressing CLDN6. This study, sponsored by Third Arc Bio, will evaluate safety, tolerability, pharmacokinetics, and antitumor activity over a 21-day toxicity assessment period.
5 Locations | NCT06672185
🆕 Phase 1/2 ETX-636 pan-mutant-selective PI3Kα inhibitor trial
This open-label study evaluates ETX-636 as monotherapy in advanced solid tumors with PIK3CA mutations and in combination with fulvestrant in HR+/HER2- metastatic breast cancer. Conducted by Ensem Therapeutics in Fairfax, it investigates safety, tolerability, pharmacokinetics, and preliminary efficacy in a first-in-human setting.
Hematological Cancer Trials
🏆 SPOTLIGHT: A New Take on an Old Drug 🔄 Phase 1 trial of ruxolitinib, a JAK1 inhibitor for preventing GVHD
Investigating biomarker-guided ruxolitinib for preventing chronic GVHD in post-transplant patients, this Phase 1 trial compares ruxolitinib monotherapy starting about 105 days after allogeneic HCT versus standard-of-care treatment. Targeting patients at high risk for chronic GVHD following transplant for blood and bone marrow malignancies, the study seeks improved long-term outcomes and is sponsored by City of Hope Medical Center.
🔄 Phase 1 HaploCord Transplant: Unmodified cord blood graft for hematologic malignancies.
This trial at Case Comprehensive Cancer Center in Cleveland investigates whether combining haplo‐identical donor and cord blood transplants can yield durable disease‐free survival in patients with AML or ALL. Patients receive this investigational transplant regimen to evaluate safety and efficacy.
🔄 Phase 1 study: Tetrahydrouridine-Decitabine, DNA methyltransferase and cytidine deaminase inhibitor combo.
This Phase 1 trial from EpiDestiny, Inc. evaluates weekly oral administrations of tetrahydrouridine followed by decitabine over 24 weeks in patients with relapsed or refractory myelodysplastic syndromes. The study focuses on safety, toxicity, and potential clinical benefit, with clinic visits every 4 weeks in the Bronx.
This summary is produced by Sagely Health. AI is used in creating some summarizations. Please check the source links.
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