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RecruitingInterventionalPhase 1

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

NCT ID: NCT07195682Sponsor: Bristol-Myers SquibbLast updated: 2026-06-09

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.

Arms & interventions

  • DrugBMS-986506

    Specified dose on specified days

Outcome measures

Primary

  • Number of Participants With Adverse Events (AEs)

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

  • Number of Participants With Serious Adverse Events (SAEs)

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

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

    Time frame: Up to approximately Day 28

  • Number of Participants With AEs Leading to Discontinuation

    Time frame: 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

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

Secondary

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

    Time frame: Up to approximately Day 85

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

    Time frame: Up to approximately Day 112

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

    Time frame: Up to approximately Day 112

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

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

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

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

  • Duration of Response (DOR) as Assessed by RECIST v1.1

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

  • Time to Response (TTR) as Assessed by RECIST v1.1

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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (5)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Stephanie Berg, Site 0006 · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Martin Voss, Site 0029 · Contact

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Recruiting
Elizabeth Plimack, Site 0002 · Contact

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting
Benjamin Garmezy, Site 0026 · Contact

START San Antonio

San Antonio, Texas, 78229

Recruiting
Amita Patnaik, Site 0001 · Contact
A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) | Cancerify