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

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

  • Advanced Solid Tumors

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