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Clinical Trial News

CAR T-cell Therapy Demonstrates Superior Overall Survival Compared to Bispecific Antibody in Multiple Myeloma

  • A real-world study comparing CAR T-cell therapies (ide-cel and cilta-cel) to the bispecific antibody teclistamab in multiple myeloma patients showed improved overall survival with CAR T.
  • The CAR T cohort experienced a lower mortality rate (20%) compared to the teclistamab cohort (30%) after one year of follow-up, with a hazard ratio of 0.62 (95% CI, 0.38-0.99).
  • While CAR T therapy was associated with a higher risk of cytokine release syndrome (CRS), no significant differences in neurotoxicity were observed between the two treatment approaches.
  • The study suggests that upfront BCMA-targeted CAR T-cell therapy may improve survival outcomes, especially in older, transplant-ineligible patients with multiple myeloma.

Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma

NCT03430011CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 2/1/2018

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

NCT04181827Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 6/12/2020

Immunocore and Bristol Myers Squibb Collaborate on Phase 3 Trial for Advanced Cutaneous Melanoma

• Immunocore partners with Bristol Myers Squibb to evaluate IMC-F106C plus nivolumab in a Phase 3 trial for advanced cutaneous melanoma. • IMC-F106C is an ImmTAC bispecific TCR candidate designed to target and destroy diseased cells by harnessing the body's immune system. • Immunocore's pipeline includes clinical-stage programs like IMC-I109V for Hepatitis B Virus (HBV) and PRAME ImmTAC candidates targeting solid tumors. • KIMMTRAK® (tebentafusp-tebn), Immunocore's approved TCR therapy, is available for metastatic uveal melanoma in multiple regions.

Luvelta Plus Bevacizumab Shows Promise in Late-Stage Ovarian Cancer

  • Sutro Biopharma's Luvelta, combined with bevacizumab, achieved a 56% objective response rate at the recommended Phase 2 dose in late-stage ovarian cancer patients.
  • The combination therapy demonstrated a 35% overall response rate, irrespective of Folate Receptor-α (FRα) expression or prior bevacizumab treatment.
  • An additional 23 patients have been enrolled in the expansion phase at the recommended dose, with initial data expected in the first half of 2025.
  • The combination showed no new safety signals compared to either agent alone, with neutropenia being the most common adverse event.

A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer

NCT05200364TerminatedPhase 1
Sutro Biopharma, Inc.
Posted 3/22/2022

REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

NCT05870748RecruitingPhase 2
Sutro Biopharma, Inc.
Posted 7/12/2023

Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic Non-small Cell Lung Cancer

NCT06555263WithdrawnPhase 2
Sutro Biopharma, Inc.
Posted 8/21/2024

Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers

NCT03748186CompletedPhase 1
Sutro Biopharma, Inc.
Posted 2/1/2019

Acrivon's ACR-368 Shows Promise in Endometrial Cancer, ACR-2316 Advances to Clinic

  • Acrivon Therapeutics reported a 62.5% confirmed overall response rate in OncoSignature-positive endometrial cancer patients treated with ACR-368 in a Phase 2 trial.
  • The study demonstrated statistically significant segregation of responders based on the OncoSignature biomarker (p = 0.009), with a median duration of response not yet reached.
  • The FDA cleared the IND for ACR-2316, a dual WEE1/PKMYT1 inhibitor, with first-in-human dosing anticipated in Q4 2024.
  • Acrivon's AP3 Interactome platform continues to generate insights for drug development and patient selection, validating its precision medicine approach.

Insights into Long COVID's Neurological Impact, MS Progression, and SCN8A-Related Disorders

  • Recent data underscores the growing concerns regarding the neurological impact of Long COVID on previously infected individuals.
  • Smoldering disease in multiple sclerosis broadens the scope beyond traditional measures, impacting disease progression independent of relapsing activity.
  • A new tool helps assess the likelihood of transitioning to secondary progressive multiple sclerosis, aiding timely treatment decisions.
  • A recent paper captures information on the estimated frequency, severity, and prognosis of comorbidities in SCN8A-related disorder phenotypes.

Camonsertib Shows Promise in ATM-Deficient Advanced Solid Tumors

• Repare Therapeutics presented Phase 1/2 TRESR trial data on camonsertib monotherapy at ESMO 2024, highlighting its potential in advanced solid tumors with ATM loss-of-function. • The study (NCT04497116) evaluated safety, pharmacokinetics, and anti-tumor activity of camonsertib, a potential leading ATR inhibitor, in patients with various solid tumors. • Early data suggests camonsertib monotherapy demonstrates preliminary anti-tumor activity in this patient population, warranting further investigation. • The oral presentation included detailed findings from Module 1 of the TRESR trial, focusing on dose escalation and expansion to determine the recommended Phase 2 dose.

Study of RP-3500, Camonsertib, in Advanced Solid Tumors

NCT04497116CompletedPhase 1
Repare Therapeutics
Posted 7/22/2020

Prelude Therapeutics' PRT3789 Shows Promise in SMARCA4-Mutated Cancers

• Prelude Therapeutics' PRT3789 demonstrated anti-tumor activity in SMARCA4-mutated NSCLC and esophageal cancer patients during Phase 1 dose escalation. • The Phase 1 trial of PRT3789 showed the drug was generally well-tolerated, with no dose-limiting toxicities or study drug-related serious adverse events. • The company aims to confirm the biologically active dose of PRT3789 by year-end and advance monotherapy and docetaxel combination studies. • Preclinical data suggests that dual SMARCA2/4 degraders attached to antibodies could expand treatment possibilities beyond SMARCA4 mutations.

Bristol Myers Squibb's Opdualag Shows Promise in Lung Cancer Phase 2 Trial

• Bristol Myers Squibb's Opdualag, combining Opdivo and relatlimab, demonstrates improved responses in certain lung cancer patients in a Phase 2 trial. • The RELATIVITY-104 trial evaluated Opdualag with chemotherapy versus Opdivo and chemotherapy alone as a first-line treatment for advanced non-small cell lung cancer. • The study aims to identify which patients benefit from adding the anti-LAG-3 drug relatlimab to the standard chemotherapy and immunotherapy regimen. • Positive results from the Phase 2 trial have propelled the Opdualag combination therapy into a Phase 3 study for advanced non-small cell lung cancer.

OneOncology CMO Highlights Critical Role of Real-World Evidence in Precision Medicine Testing

  • Dr. Davey Daniel emphasizes that real-world evidence is crucial for understanding NGS testing benefits and determining the value of emerging technologies like MRD testing in cancer care.
  • Cost-effectiveness in precision medicine hinges on identifying drugs with high response likelihood, with unsuccessful treatments representing the highest economic burden for patients.
  • Sequential testing in cancer care presents opportunities for monitoring treatment resistance and optimizing therapy decisions, though challenges remain in proving long-term survival benefits.

Oncternal Therapeutics Halts Clinical Trials, Initiates Layoffs After Disappointing Results

  • Oncternal Therapeutics discontinues clinical trials for ONCT-534 in prostate cancer and ONCT-808 in B-cell lymphoma due to lackluster Phase I results and a patient death.
  • The company's stock price plummeted by 60% following the announcement, leading to a restructuring that includes laying off 37% of its workforce.
  • This decision follows previous trial terminations of zilovertamab, a tyrosine kinase inhibitor, in April 2023, compounding financial pressures.
  • Oncternal plans to explore alternative options for its programs while focusing on cost reduction measures and workforce optimization.

A Clinical Study of ONCT-808 in Subjects With Relapsed or Refractory B-Cell Malignancies

NCT05588440TerminatedPhase 1
Oncternal Therapeutics, Inc
Posted 5/9/2023

A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.

NCT05917470TerminatedPhase 1
Oncternal Therapeutics, Inc
Posted 9/20/2023

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