A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
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.
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.
Not Available
Phase I/II
Adults
Not Available
Not Available
Berlin, Jordan
International
Vanderbilt University
10-28-2024
Eligibility
18 Years
BOTH
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/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
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
