A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

What this study is about

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, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
• Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.

🚫 You may not be able to join if…

• Women who are pregnant or breastfeeding.
• Primary central nervous system (CNS) malignancy.
• Untreated CNS metastases.
• Leptomeningeal metastases.
• Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
• Active, known, or suspected autoimmune disease.
• Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
• Prior organ or tissue allograft.
• Uncontrolled or significant cardiovascular disease.
• Major surgery within 4 weeks of study drug administration.
• History of or with active interstitial lung disease or pulmonary fibrosis.
• Other protocol-defined inclusion/exclusion criteria apply.

Where this trial is running

• Community Cancer Institute, Clovis, California, United States
• USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
• University of Iowa, Iowa City, Iowa, United States
• John Theurer Cancer Center, Hackensack, New Jersey, United States
• Local Institution - 0006, New York, New York, United States
• Local Institution - 0002, New York, New York, United States
• Providence Cancer Center Oncology and Hematology Care- Eastside, Portland, Oregon, United States
• Local Institution - 0063, Nashville, Tennessee, United States
• Vanderbilt University Medical Center, Nashville, Tennessee, United States
• Houston Methodist Hospital, Houston, Texas, United States
• Blacktown Hospital, Blacktown, New South Wales, Australia

+ 35 more sites.

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04895709.