First human testing of BMS-986506 in advanced clear cell kidney cancer
A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
PHASE1 · Bristol-Myers Squibb · NCT07195682
This will test whether the experimental drug BMS-986506 is safe and tolerable when taken alone by people with advanced or metastatic clear cell kidney cancer who have already received prior treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Drugs / interventions | immunotherapy |
| Locations | 9 sites (Boston, Massachusetts and 8 other locations) |
| Trial ID | NCT07195682 on ClinicalTrials.gov |
What this trial studies
This Phase 1, first-in-human interventional study gives escalating doses of the experimental agent BMS-986506 to adults with locally advanced or metastatic clear cell renal cell carcinoma to define safety and tolerability. The trial includes an initial dose-finding portion and a subsequent cohort-based expansion for participants with prior exposure to standard therapies such as PD-1/PD-L1 inhibitors and VEGF-targeted agents. Eligible participants must have histologically confirmed ccRCC and an ECOG performance status of 0–1, and some cohorts require specific prior treatment histories. Key exclusions include inability to take oral medication as formulated and significant hypoxia or excessive prior systemic regimens for certain cohorts.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed locally advanced or metastatic clear cell RCC, ECOG 0–1, and prior therapy exposure consistent with the protocol (for example prior immunotherapy and targeted therapy or prior PD-1/L1 plus VEGF-TKI depending on the cohort).
Not a fit: Patients who cannot swallow or tolerate the oral drug formulation, have resting hypoxia (pulse oximetry <92%), or who exceed allowed prior systemic regimens for specific cohorts are unlikely to benefit from joining this phase 1 safety-focused trial.
Why it matters
Potential benefit: If successful, BMS-986506 could add a new treatment option for people whose clear cell kidney cancer has progressed after current standard therapies.
How similar studies have performed: This agent is being tested in humans for the first time, though other targeted and immune-based therapies have shown clinical benefit in clear cell RCC while this specific drug's efficacy is unproven.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 8 other locations
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)
- SCRI Oncology Partners — Nashville, Tennessee, United States (RECRUITING)
- START San Antonio — San Antonio, Texas, United States (RECRUITING)
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (RECRUITING)
- Gustave Roussy — Villejuif, Val-de-Marne, France (RECRUITING)
- Hospital Universitario Reina Sofia — Córdoba, Andalusia, Spain (RECRUITING)
- Local Institution - 0018 — Barcelona, Barcelona [Barcelona], Spain (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Renal Cell Carcinoma, Metastatic clear cell renal cell carcinoma, Advanced clear cell renal cell carcinoma, ccRCC, Kidney cancer