RecruitingPhase 1NCT07195682

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

A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)


Sponsor

Bristol-Myers Squibb

Enrollment

125 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

Interventions

DRUGBMS-986506

Specified dose on specified days


Locations(9)

Local Institution - 0006

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Local Institution - 0002

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

START San Antonio

San Antonio, Texas, United States

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Local Institution - 0008

Villejuif, Val-de-Marne, France

Local Institution - 0015

Córdoba, Andalusia, Spain

Local Institution - 0018

Barcelona, Barcelona [Barcelona], Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07195682


Related Trials