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

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT06730750

This study evaluates BMS-986490 alone or with bevacizumab in advanced solid tumors expressing CEACAM5. Eligible participants have advanced, unresectable/metastatic tumors, including CRC, NSCLC, and GC, with specific progression criteria. Interventions involve specified doses of BMS-986490 and bevacizumab. Participants must meet RECIST v1.1 and ECOG performance status of 0 or 1.

Patient Parameters

Program 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.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
Local Institution - 000790033Los AngelesCalifornia
START Midwest49546Grand RapidsMichigan
Local Institution - 000407601HackensackNew Jersey
Local Institution - 000615232PittsburghPennsylvania

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