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

Sponsor: Bristol-Myers Squibb

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04895709

This first-in-human study evaluates BMS-986340's safety and tolerability in advanced solid tumors. Participants must provide tumor biopsies, have measurable disease per RECIST v1.1, and meet specific health criteria. Interventions include BMS-986340, nivolumab, and docetaxel, administered in specified doses. Eligibility requires prior standard-of-care therapies and documented disease progression.

Patient Parameters

Program 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.

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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