Advanced Solid Tumors
Conditions
Keywords
Colorectal Cancer (CRC), Non-small Cell Lung cancer (NSCLC), Gastric Cancer (GC)
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.
Interventions
DRUGBMS-986490
Specified dose on specified days.
DRUGBevacizumab
Specified dose on specified days.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| Maximum observed concentration (Cmax) | Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days) |
| 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) |
| Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by Investigator | Up to approximately 4 years |
Countries
Australia, Canada, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed