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

Purpose

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.

Condition

  • Renal Cell Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BMS-986506: Part 1A
  • Drug: BMS-986506
    Specified dose on specified days
Experimental
BMS-986506: Part 2A
  • Drug: BMS-986506
    Specified dose on specified days
Experimental
BMS-986506: Part 2B
  • Drug: BMS-986506
    Specified dose on specified days

Recruiting Locations

Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Stephanie Berg, Site 0006
617-632-4932

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Martin Voss, Site 0029
646-888-4721

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Elizabeth Plimack, Site 0002
215-728-3889

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
Benjamin Garmezy, Site 0026
713-444-7804

START San Antonio
San Antonio, Texas 78229
Contact:
Amita Patnaik, Site 0001
210-593-5250

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com