About this trial
The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.
Participants must have an unresectable/metastatic carcinoma.
Disqualifiers
Participants must not have Leptomeningeal metastases.
Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment.
Other protocol-defined Inclusion/Exclusion criteria apply.
Trial design
Sequential
Treatments tested in this trial
BMS-986463
DrugSpecified dose on specified days
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Number of participants with AEs leading to discontinuation
Secondary outcomes
Maximum observed concentration (Cmax)
Area under the concentration-time curve (AUC)
Time of maximum observed concentration (Tmax)
Objective response rate (ORR)
Sponsors and contacts
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