assignment
Recruiting

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

location_city
2
research sites
public
2
countries
medical_information
1
disease
person_search
3
investigators

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

Please provide the source data containing the names of the medications, dosages, routes of administration, and other treatment details. Without the source data, it is impossible to generate the specific description required.

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 FranceRecruiting01 Mar 202616
Spain SpainRecruiting01 Mar 202632

Sites & Investigators

Conditions Studied in This Trial