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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Specified dose on specified days.
Specified dose on specified days.
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
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
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)
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Tasman Oncology Research
Southport, Queensland, Australia
Local Institution - 0003
Toronto, Ontario, Canada
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