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THIS WEEK’S BREAKTHROUGHS:
🏆 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:
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)
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!
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.
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
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
🏆 SPOTLIGHT: Convenience + high remission rate = great outcomeBlinatumomab, 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
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
🆕 18 First-in-human 🔄 40 Expansion ✅ 8 Registrational🏆 SPOTLIGHT: New phase III for HR+ PI3K-mutated BCThis 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
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
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.
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.
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.
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
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.
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
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.
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
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
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.
🏆 SPOTLIGHT: Next-gen EZH2 inhibitor + AR Blockade Heads to Phase 3This 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
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
🏆 SPOTLIGHT: A new DLL3 ADCThis 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
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.
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.
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.
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.
🏆 SPOTLIGHT: A New Frontline Treatment for High-Risk MyelomaThis 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.
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.
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
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
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.
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
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.
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
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.
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.
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
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.
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
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.
🏆 SPOTLIGHT: A New Pan-RAS Inhibitor Enters the ClinicThis 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 + KRASThis 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!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.
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
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
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.
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.
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.
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
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
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
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
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
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
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.
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.
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
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
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
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.
🏆 SPOTLIGHT: A New Take on an Old DrugInvestigating 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.
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.
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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