RecruitingPhase 1Phase 2NCT06730750

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

A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors


Sponsor

Bristol-Myers Squibb

Enrollment

360 participants

Start Date

Feb 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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, 2L+ NSCLC:
  • i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.
  • ii) 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 Criteria3

  • History of anaphylactic reactions to irinotecan and/or bevacizumab.
  • Previously received therapy targeting CEACAM5.
  • Grade ≥3 ILD/pneumonitis.

Interventions

DRUGBMS-986490

Specified dose on specified days.

DRUGBevacizumab

Specified dose on specified days.


Locations(6)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

START Midwest

Grand Rapids, Michigan, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Tasman Oncology Research

Southport, Queensland, Australia

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06730750


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