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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Renal Cell Carcinoma

Treatments: Drug: BMS-986506

Study type: Interventional

Funder types: Industry

Identifiers

NCT07195682

CA242-0001

U1111-1323-5879 (Other Identifier)

2025-522543-18 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 3 patient groups

BMS-986506: Part 1A

Experimental group

Treatment:

Drug: BMS-986506

BMS-986506: Part 2A

Experimental group

Treatment:

Drug: BMS-986506

BMS-986506: Part 2B

Experimental group

Treatment:

Drug: BMS-986506