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NCT Number: NCT07195682

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986506

Drug

Specified dose on specified days

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

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

  2. Number of Participants With Serious Adverse Events (SAEs)

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

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

    Time frame: Up to approximately Day 28

  4. Number of Participants With AEs Leading to Discontinuation

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

  5. 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 outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of BMS-986506

    Time frame: Up to approximately Day 85

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

    Time frame: Up to approximately Day 112

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

    Time frame: Up to approximately Day 112

  4. 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

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

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

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Sep 29, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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