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RecruitingPhase 1NCT07195682

A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

Trial Parameters

ConditionRenal Cell Carcinoma
SponsorBristol-Myers Squibb
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment125
SexALL
Min Age18 Years
Max AgeN/A
Start Date2026-01-15
Completion2030-05-03
Interventions
BMS-986506

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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 intermitt

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