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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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, 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 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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1A
  • Drug: BMS-986490
    Specified dose on specified days.
Experimental
Part 2A - Colorectal Cancer (CRC)
  • Drug: BMS-986490
    Specified dose on specified days.
Experimental
Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC)
  • Drug: BMS-986490
    Specified dose on specified days.
Experimental
Part 1B
  • Drug: BMS-986490
    Specified dose on specified days.
  • Drug: Bevacizumab
    Specified dose on specified days.
Experimental
Part 2B
  • Drug: BMS-986490
    Specified dose on specified days.
  • Drug: Bevacizumab
    Specified dose on specified days.

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.