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RecruitingInterventionalPhase 1

A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

NCT ID: NCT06764771Sponsor: Bristol-Myers SquibbLast updated: 2026-06-03

Summary

This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.

Arms & interventions

  • DrugBMS-986488

    Specified dose on specified days

  • DrugAdagrasib

    Specified dose on specified days

  • DrugCetuximab

    Specified dose on specified days

  • DrugNivolumab

    Specified dose on specified days

Outcome measures

Primary

  • Number of participants with Adverse Events (AEs)

    Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)

  • Number of participants with Serious AEs (SAEs)

    Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)

  • Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria

    Time frame: From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)

  • Number of participants with AEs leading to discontinuation

    Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)

  • Number of deaths

    Time frame: From time of informed consent up to 52 weeks after end of treatment visit

Secondary

  • Maximum observed plasma concentration (Cmax)

    Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)

  • Time of maximum observed concentration (Tmax)

    Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)

  • Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

    Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)

  • Objective response rate (ORR)

    Time frame: From time of informed consent up to 52 weeks after end of treatment visit

  • Disease control rate (DCR)

    Time frame: From time of informed consent up to 52 weeks after end of treatment visit

  • Duration of response (DOR)

    Time frame: From time of informed consent up to 52 weeks after end of treatment visit

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Participant must be ≥ 18 years of age. * Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:. * Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC). * Parts 2A, 1D, 2D: ccRCC. i) Part 1B: solid tumors with KRAS G12C mutation. ii) Part 2B: NSCLC with KRAS G12C mutation. iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation. * Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1. * Participants must have measurable disease per RECIST v1.1. Exclusion Criteria: * Untreated central nervous system (CNS) metastases. * Leptomeningeal metastasis (carcinomatous meningitis). * Impaired cardiac function or clinically significant cardiac disease. * For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):. i) History of pneumonitis or interstitial lung disease (ILD). ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). \- Other protocol-defined inclusion/exclusion criteria apply.

Study locations (4)

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting
Martin Gutierrez, Site 0021 · Contact

Local Institution - 0020

Allentown, Pennsylvania, 18103

Active Not Recruiting

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee, 38138

Recruiting
Daniel Vaena, Site 0024 · Contact

Local Institution - 0025

Dallas, Texas, 75390

Withdrawn