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Trial ID CA238-0001  |   NCT06730750

A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors

Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 6
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.
    1. CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:.
      1. 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).
      2. NSCLC: Part 2A-NSCLC/GC, 3L+ NSCLC:.
        1. Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.
          1. Progressed on at least 2 prior lines of therapy,
            1. Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.
            2. GC: Part 2A-NSCLC/GC, 2L+ GC:.
              1. 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).
                1. ECOG performance status of 0 or 1.

                Exclusion Criteria

                Exclusion Criteria Icon
                :
                • History of anaphylactic reactions to irinotecan and/or bevacizumab.
                  1. Previously received therapy targeting CEACAM5.
                    1. Grade ≥ 3 ILD/pneumonitis.
                      Additional Information *
                      • Other protocol-defined Inclusion/Exclusion criteria apply.

                        Treatment Options

                        Study Arms

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Part 1A

                        ASSIGNED INTERVENTION
                        • Drug: BMS-986490

                        Study Arms

                        Experimental: Part 1B

                        ASSIGNED INTERVENTION
                        • Drug: BMS-986490, Bevacizumab

                        Study Arms

                        Experimental: Part 2A - Colorectal Cancer (CRC)

                        ASSIGNED INTERVENTION
                        • Drug: BMS-986490

                        Study Arms

                        Experimental: Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC)

                        ASSIGNED INTERVENTION
                        • Drug: BMS-986490

                        Study Arms

                        Experimental: Part 2B

                        ASSIGNED INTERVENTION
                        • Drug: BMS-986490, Bevacizumab
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