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

Introduction

• Org Study ID: CA052-002
• NTC ID: NCT04895709
• Lead Sponsor Name: Bristol-Myers Squibb
• Status: RECRUITING

Conditions

• Renal Cell Carcinoma

Brief Summary

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