Overview

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.

Principal investigator

Douglas Laux
Internal Medicine

Eligibility criteria

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/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. Exclusion Criteria
*  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
Show more

Participate in this trial

Are you interested in enrolling in this study? Learn more here.

I'm Interested In Participating

For Referring Providers

Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.

Contact the study coordinator

Mariel Mimi McKay
Enroll your patient