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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

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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