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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06730750
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