This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC.
Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.
For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.
For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other).
Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Participants with Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.
For Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.
Participants who have hypoxia as defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen.
Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.
Single group
BMS-986506
DrugSpecified dose on specified days
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
Maximum Observed Plasma Concentration (Cmax) of BMS-986506
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506
Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
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