A Phase I/II Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Study Identifier:
CA1201001
CT.gov Identifier:
NCT05888831
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2023-503484-42-00
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.

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/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose Escalation
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • - All participants must have a histologically or cytologically confirmed, advanced,
    • unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria
    • in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for,
    • or intolerant of existing therapy(ies) known to provide clinical benefit for the
    • condition of the participant.
    • - Part 1A may have a solid malignancy of any histology.
    • - Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
    • - Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).
    • - Tumor biopsy must be obtained for all participants (unless medically precluded).
    Exclusion criteria
    • - History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor
    • therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD-
    • 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or drug
    • specifically targeting T-cell co-stimulation or other immune checkpoint pathways)
    • except those that are unlikely to re-occur with standard countermeasures.
    • - Current or recent (within 3 months of study intervention administration)
    • gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon
    • resection) that could impact the absorption of study intervention.
    • - Any significant acute or chronic medical illness which would interfere with study
    • intervention or follow-up in the opinion of the investigator.
    • Other protocol-defined criteria may apply.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor