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

NCT07195682 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA242-00012025-522543-18U1111-1323-5879
• Study Type: interventional
• Target: 125
• Locations: 4 countries
• Sites: 9

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.

Conditions

Renal Cell Carcinoma

Keywords

Metastatic clear cell renal cell carcinoma; Advanced clear cell renal cell carcinoma; ccRCC; Kidney cancer

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Adverse Events (AEs)

  Up to approximately 2 years from first dose of BMS-986506

• Number of Participants With Serious Adverse Events (SAEs)

  Up to approximately 2 years from first dose of BMS-986506

• Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria

  Up to approximately Day 28

• Number of Participants With AEs Leading to Discontinuation

  Up to approximately 2 years from first dose of BMS-986506

• Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0

  Up to approximately 2 years from first dose of BMS-986506

Secondary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of BMS-986506

  Up to approximately Day 85

• Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506

  Up to approximately Day 112

• Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506

  Up to approximately Day 112

• Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

  Up to approximately 3 years from first dose of BMS-986506

• Disease Control Rate (DCR) as Assessed by RECIST v1.1

  Up to approximately 3 years from first dose of BMS-986506

Study Arms (3)

BMS-986506: Part 1A

EXPERIMENTAL

Drug: BMS-986506

BMS-986506: Part 2A

EXPERIMENTAL

Drug: BMS-986506

BMS-986506: Part 2B

EXPERIMENTAL

Drug: BMS-986506

Interventions

BMS-986506 DRUG

Specified dose on specified days

BMS-986506: Part 1A; BMS-986506: Part 2A; BMS-986506: Part 2B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (9)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

Gustave Roussy

Villejuif, Val-de-Marne, 94800, France

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain

RECRUITING

Local Institution - 0018

Barcelona, Barcelona [Barcelona], 08035, Spain

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Renal Cell; Clear-cell metastatic renal cell carcinoma; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: September 29, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): May 3, 2030
• Study Completion (Estimated): April 3, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (5); ES (2); FR (1); CA (1)