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NCT07195682PHASE1Recruiting

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

Bristol-Myers Squibb

Start Date

1/15/2026

Completion Date

4/3/2031

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

Age Range: 18 years to No maximum

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 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. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

BMS-986506

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Conditions

Renal Cell Carcinoma

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

START San Antonio

San Antonio, Texas 78229

United States

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Gustave Roussy

Villejuif, Val-de-Marne 94800

France

Hospital Universitario Reina Sofia

Córdoba, Andalusia 14004

Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona] 08035

Spain