A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT06730750
This study evaluates BMS-986490 alone or with bevacizumab in advanced solid tumors expressing CEACAM5. Eligible participants have advanced, unresectable/metastatic tumors, including CRC, NSCLC, and GC, with specific progression criteria. Interventions involve specified doses of BMS-986490 and bevacizumab. Participants must meet RECIST v1.1 and ECOG performance status of 0 or 1.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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
Inclusion Criteria
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Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.
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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).
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NSCLC: Part 2A-NSCLC/GC, 3L+ NSCLC:.
i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.
ii) Progressed on at least 2 prior lines of therapy,
iii) 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0007 | 90033 | Los Angeles | California |
| START Midwest | 49546 | Grand Rapids | Michigan |
| Local Institution - 0004 | 07601 | Hackensack | New Jersey |
| Local Institution - 0006 | 15232 | Pittsburgh | Pennsylvania |
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