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Recruiting NCT07195682

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

Phase I Interventional Renal Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986506.
Who it may be relevant to
Registry conditions: Renal Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, France, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug BMS-986506
    Specified dose on specified days

Primary outcome measures

  • 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 outcome measures (7)
  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Dana-Farber Cancer Institute — Boston
  • Memorial Sloan Kettering Cancer Center — New York
  • Fox Chase Cancer Center — Philadelphia
  • SCRI Oncology Partners — Nashville
  • START San Antonio — San Antonio
Spain · 2 centers
  • Hospital Universitario Reina Sofia — Córdoba
  • Hospital Universitari Vall d'Hebron — Barcelona
Canada · 1 center
  • Arthur J.E. Child Comprehensive Cancer Centre — Calgary
France · 1 center
  • Gustave Roussy — Villejuif

Identifiers

NCT: NCT07195682 · CA242-0001 · 2025-522543-18 · U1111-1323-5879

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗