Status:
RECRUITING
A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 3 2031
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT07195682
Start Date
December 31 2025
End Date
April 3 2031
Last Update
December 30 2025
Active Locations (9)
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1
Local Institution - 0006
Boston, Massachusetts, United States, 02215
2
Local Institution - 0029
New York, New York, United States, 10065
3
Local Institution - 0002
Philadelphia, Pennsylvania, United States, 19111
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203