A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Bristol-Myers Squibb
Summary
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable. * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Radiographically documented progressive disease on or after the most recent therapy. * Received standard-of-care therapies, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastat…
Interventions
- DrugBMS-986340
Specified dose on specified days
- DrugBMS-936558-01
Specified dose on specified days
- DrugDocetaxel
Specified dose on specified days
Locations (48)
- Community Cancer InstituteClovis, California
- USC/Norris Comprehensive Cancer CenterLos Angeles, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- University of IowaIowa City, Iowa
- John Theurer Cancer CenterHackensack, New Jersey
- Local Institution - 0006New York, New York