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

NCT ID: NCT07195682

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2031-04-03

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986506: Part 1A

Group Type EXPERIMENTAL

BMS-986506

Intervention Type DRUG

Specified dose on specified days

BMS-986506: Part 2A

Group Type EXPERIMENTAL

BMS-986506

Intervention Type DRUG

Specified dose on specified days

BMS-986506: Part 2B

Group Type EXPERIMENTAL

BMS-986506

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986506

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0006

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0029

New York, New York, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0002

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

START San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Local Institution - 0021

Calgary, Alberta, Canada

Site Status NOT_YET_RECRUITING

Local Institution - 0008

Villejuif, Val-de-Marne, France

Site Status NOT_YET_RECRUITING

Local Institution - 0015

Córdoba, Andalusia, Spain

Site Status NOT_YET_RECRUITING

Local Institution - 0018

Barcelona, Barcelona [Barcelona], Spain

Site Status NOT_YET_RECRUITING

Countries

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United States Canada France Spain

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

Phone: 8559073286

Email: [email protected]

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

Role: CONTACT

Facility Contacts

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Site 0006

Role: primary

Site 0029

Role: primary

Site 0002

Role: primary

Benjamin Garmezy, Site 0026

Role: primary

Amita Patnaik, Site 0001

Role: primary

Site 0021

Role: primary

Site 0008

Role: primary

Site 0015

Role: primary

Site 0018

Role: primary

Related Links

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Other Identifiers

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2025-522543-18

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1323-5879

Identifier Type: OTHER

Identifier Source: secondary_id

CA242-0001

Identifier Type: -

Identifier Source: org_study_id