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
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For Referring Providers

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Contact the study coordinator

Mariel Mimi McKay
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