A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Purpose
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.
Conditions
- Cervical Cancer
- Gastric/Gastroesophageal Junction Adenocarcinoma
- Microsatellite Stable Colorectal Cancer
- Non-Small-Cell Lung Cancer
- Squamous Cell Carcinoma of Head and Neck
- Carcinoma, Renal Cell
- Urothelial Carcinoma
- Pancreatic Adenocarcinoma
- Melanoma
- Ovarian Neoplasms
- Triple Negative Breast Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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, 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.
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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Experimental Part 1A: BMS-986340 Dose Escalation |
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Experimental Part 2A: BMS-986340 Dose Expansion |
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Experimental Part 1B: BMS-986340 + Nivolumab Dose Escalation |
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Experimental Part 2B: BMS-986340 + Nivolumab Dose Expansion |
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Experimental Part 1C: BMS-986340 + Docetaxel Dose Escalation |
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Experimental Part 1A-J: BMS-986340 Dose Escalation |
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Experimental Part 1B-J: BMS-986340 + Nivolumab Dose Escalation |
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Experimental Part 2C: BMS-986340 + Docetaxel Dose Expansion |
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Experimental Part 2D: BMS-986340 + Pumitamig Dose Expansion |
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Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Jordan Berlin, Site 0052
615-936-1796
Jordan Berlin, Site 0052
615-936-1796
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com