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

Study Identifier:
CA233-0000
CT.gov Identifier:
NCT06544655
EudraCT Identifier:
2024-513696-40
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1A
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  • Drug: Experimental: Part 1B
  • Drug: Biological: Nivolumab
  • Drug: Experimental: Part 2A
  • Drug: Experimental: Part 2B
  • Drug: Experimental: Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation
  • Drug: Drug: BMS-986484
  • Drug: Drug: Capecitabine
  • Drug: Experimental: Part 1 Co-Admin: BMS-986484 + Nivolumab
  • Drug: Experimental: Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation
  • Drug: Experimental: Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • * Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN).
    • * Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
    • * Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
    Exclusion criteria
    • * History of or with active interstitial lung disease or pulmonary fibrosis.
    • * Active, known, or suspected autoimmune disease.
    • * Serious uncontrolled medical disorders.
    • * New onset, non-catheter-associated venous thromboembolism within the past 6 months.
    • * Other protocol-defined Inclusion/Exclusion criteria apply.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor