NCT06730750PHASE1, PHASE2Recruiting
A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
Bristol-Myers Squibb
Start Date
2/12/2025
Completion Date
12/9/2029
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 Criteria
Age Range: 18 years to No maximum
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.
Interventions
DRUG
BMS-986490
DRUG
Bevacizumab
Conditions
Advanced Solid Tumors
Locations
Local Institution - 0007
Los Angeles, California 90033
United States
Local Institution - 0017
Grand Rapids, Michigan 49546
United States
Local Institution - 0004
Hackensack, New Jersey 07601
United States
Local Institution - 0006
Pittsburgh, Pennsylvania 15232
United States
Tasman Oncology Research
Southport, Queensland 4215
Australia
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada