A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
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.
Arms & interventions
- DrugBMS-986490
Specified dose on specified days.
- DrugBevacizumab
Specified dose on specified days.
Outcome measures
Primary
Number of participnats with Adverse Events (AEs)
Time frame: Up to 100 days following discontinuation of dosing
Number of participants with Serious AEs (SAEs)
Time frame: Up to 100 days following discontinuation of dosing
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Time frame: Up to 28 days after the first treatment of study intervention
Number of participants with AEs leading to discontinuation
Time frame: Up to 100 days following discontinuation of dosing
Number of deaths
Time frame: Up to 100 days following discontinuation of dosing
Secondary
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Trough observed concentration (Ctrough)
Time frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Maximum observed concentration (Cmax)
Time frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Time of maximum observed concentration (Tmax)
Time frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Total anti-drug antibodies (ADAs)
Time frame: 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
Time frame: Up to approximately 4 years
Eligibility criteria
Study locations (4)
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
START Midwest
Grand Rapids, Michigan, 49546
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232