A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Recruiting now · Phase 1
Conditions studied: Renal Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07195682
- Run by
- Bristol-Myers Squibb
- People needed
- 125
- Starts
- 2026-01-15
- Expected to finish
- 2031-04-03
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- START San Antonio — San Antonio, Texas, United States (enrolling)
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (enrolling)
- Gustave Roussy — Villejuif, Val-de-Marne, France (enrolling)
- Hospital Universitario Reina Sofia — Córdoba, Andalusia, Spain (enrolling)
- Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [Barcelona], Spain (enrolling)
Full record on ClinicalTrials.gov
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