RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Documented diagnosed by tissue sample (biopsy-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) diagnosed by tissue sample (biopsy-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) You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
BMS-986490
Specified dose on specified days.
DRUG
Bevacizumab
Specified dose on specified days.
Locations (6)
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
START Midwest
Grand Rapids, Michigan, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Tasman Oncology Research
Southport, Queensland, Australia
Princess Margaret Cancer Centre
Toronto, Ontario, Canada