A Phase 1/1b First-in-Human Study to Evaluate the Safety and Pharmacokinetics of BMS-986506 in Patients with Advanced Clear Cell Renal Cell Carcinoma
- Trial ID
- 2025-522543-18-00
- Protocol
- CA242-0001
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this phase 1/1b first-in-human study is to evaluate the safety and pharmacokinetics of BMS-986506 in patients diagnosed with advanced clear cell renal cell carcinoma. This assessment is critical for establishing the initial safety profile and determining the metabolic characteristics of the investigational product in a clinical setting.
Participants
The study population consists of 77 patients diagnosed with advanced clear cell renal cell carcinoma. The cohort includes both male and female participants. Based on the provided age range codes, the subjects fall within specific age categories. The sponsor did not provide additional information regarding lifestyle considerations or selection methodologies.
Plans and Procedures
This Phase 1/1b, first-in-human study evaluates the safety and efficacy of BMS-986506 in patients with advanced clear cell renal cell carcinoma. The trial design involves a sequence of study visits, beginning with a screening visit to determine eligibility. Following enrollment, participants undergo periodic follow-up visits to monitor clinical responses and safety parameters. The process concludes with an end-of-study visit. The total duration of participant involvement is determined by individual clinical progress and specific study protocols. Early termination from the study may occur based on predefined discontinuation criteria or clinical necessity.
Treatment
Efficacy
The assessment of efficacy in this phase 1 clinical trial for advanced clear cell renal cell carcinoma is not specified in the provided documentation.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
France | Recruiting | 01 Mar 2026 | 16 |
Spain | Recruiting | 01 Mar 2026 | 32 |


