A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies

Trial Details

Sponsor: Bristol-Myers Squibb (industry)

Phase: 1

Start date: Oct. 10, 2024

Planned enrollment: 134

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Trial ID: NCT06544655

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More trial details at ClinicalTrials.gov

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Goal: The goal of the trial is to assess the safety, tolerability, and preliminary efficacy of BMS-986484, both as monotherapy and in combination with nivolumab, in patients with advanced or metastatic solid tumors.

Patients: The study includes adult patients with locally advanced unresectable, metastatic, or recurrent malignant tumors such as non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal cancer, pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN). Eligible patients must have measurable disease per RECIST v1.1 and an ECOG performance status of 0 or 1.

Design: This is a non-randomized, phase 1/1b, first-in-human study with planned enrollment of 134 participants. The study consists of both dose escalation and dose expansion cohorts investigating BMS-986484 alone and in combination with nivolumab.

Treatments: BMS-986484, the investigational agent, is being studied alone and in combination with nivolumab. BMS-986484 is an investigational biologic, believed to be an anti-FAP (fibroblast activation protein) agent, currently in early clinical development. Its precise mechanism of action has not been fully disclosed, and no human efficacy results are currently available. Nivolumab, an anti-PD-1 immunotherapy, is used in combination arms as a comparator and potential enhancer of activity.

Outcomes: Primary endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), protocol-defined dose-limiting toxicities (DLTs), AEs leading to discontinuation, and AEs leading to death. Secondary endpoints focus on pharmacokinetics (Cmax, Tmax, AUC), incidence of anti-drug antibodies, and measures of clinical activity including objective response rate (ORR), disease control rate (DCR), and duration of response (DOR), all assessed by RECIST v1.1 criteria.

Burden on patient: Patient burden for this phase 1 trial is expected to be high. Participants will undergo frequent safety assessments, regular pharmacokinetic blood draws, immunogenicity blood draws for anti-drug antibodies, and imaging studies per protocol to monitor disease. Dose escalation and expansion phases typically require close monitoring, more intensive visit schedules, and may include additional biopsies depending on exploratory biomarker analyses. Travel for frequent study visits and additional procedures beyond standard of care are likely.

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