A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
- Conditions
- Interventions
- Registration Number
- NCT06730750
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 360
-
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, 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1A BMS-986490 - Part 2A - Colorectal Cancer (CRC) BMS-986490 - Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC) BMS-986490 - Part 1B BMS-986490 - Part 1B Bevacizumab - Part 2B BMS-986490 - Part 2B Bevacizumab -
- Primary Outcome Measures
Name Time Method Number of participnats with Adverse Events (AEs) Up to 100 days following discontinuation of dosing Number of participants with Serious AEs (SAEs) Up to 100 days following discontinuation of dosing Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria Up to 28 days after the first treatment of study intervention Number of participants with AEs leading to discontinuation Up to 100 days following discontinuation of dosing Number of deaths Up to 100 days following discontinuation of dosing
- Secondary Outcome Measures
Name Time Method Time of maximum observed concentration (Tmax) Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days) Total anti-drug antibodies (ADAs) Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days) Maximum observed concentration (Cmax) Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days) Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days) Trough observed concentration (Ctrough) Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days) Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by Investigator Up to approximately 4 years
Trial Locations
- Locations (6)
Local Institution - 0007
🇺🇸Los Angeles, California, United States
Local Institution - 0017
🇺🇸Grand Rapids, Michigan, United States
Local Institution - 0004
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0006
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0012
🇦🇺Southport, Queensland, Australia
Local Institution - 0003
🇨🇦Toronto, Ontario, Canada