A Phase I/IIa, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors

Study Identifier:
CA238-0001
CT.gov Identifier:
NCT06730750
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study Summary

This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.

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: Part 1A
    • Read More
  • Drug: Experimental: Part 2A - Colorectal Cancer (CRC)
  • Drug: Experimental: Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC)
  • Drug: Experimental: Part 1B
  • Drug: Drug: Bevacizumab
  • Drug: Experimental: Part 2B
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.
    • CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:.
    • i) Locally advanced/metastatic, recurrent, or unresectable CRC with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-FU, irinotecan, and/or oxaliplatin (if available and not contraindicated).
    • NSCLC: Part 2A-NSCLC/GC, 3L+ NSCLC:.
    • i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.
    • ii) Progressed on at least 2 prior lines of therapy,
    • iii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.
    • - GC: Part 2A-NSCLC/GC, 2L+ GC:.
    • i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).
    • ii) ECOG performance status of 0 or 1.
    Exclusion criteria
    • History of anaphylactic reactions to irinotecan and/or bevacizumab.
    • Previously received therapy targeting CEACAM5.
    • Grade ≥ 3 ILD/pneumonitis.
    • 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
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor