Testing BMS-986490 with or without Bevacizumab for 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
This study is testing a new treatment called BMS-986490, with and without another drug called bevacizumab, to see if it helps people with advanced solid tumors like colorectal, non-small cell lung, and gastric cancer who haven't had success with other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | bevacizumab |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT06730750 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of BMS-986490, both alone and in combination with bevacizumab, in patients with advanced solid tumors that express CEACAM5. Participants include those with colorectal cancer, non-small cell lung cancer, and gastric cancer who have not responded to previous treatments. The study aims to determine the safety and efficacy of these treatments in this specific patient population. It is conducted in multiple phases to assess both initial responses and longer-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced, unresectable solid tumors, specifically colorectal cancer, non-small cell lung cancer, or gastric cancer, who have progressed after standard therapies.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have limited treatment alternatives.
How similar studies have performed: Other studies have shown promise with similar therapeutic approaches, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 5 other locations
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Tasman Oncology Research — Southport, Queensland, Australia (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.