Recruiting

A Study of BMS-986340 as Monotherapy and as Combination Therapy 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, 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.

ClinicalTrials.gov IDNCT04895709

PhasePHASE1, PHASE2

Enrollment1109

SponsorBristol-Myers Squibb

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

Interventions

Drug: BMS-986340 — Specified dose on specified days
Drug: BMS-936558-01 — Specified dose on specified days
Drug: Docetaxel — Specified dose on specified days
Drug: Pumitamig — Specified dose on specified days

Primary outcomes

Incidence of adverse events (AEs) (Up to 120 weeks)
Incidence of serious adverse events (SAEs) (Up to 120 weeks)
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria (Up to either 21 or 28 days)
Incidence of AEs leading to discontinuation (Up to 120 weeks)
Number of deaths (Up to 120 weeks)

Eligibility information

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 locations

Community Cancer Institute, Clovis, California 93611 United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California 90033 United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California 92663 United States
University of Iowa, Iowa City, Iowa 52242 United States
John Theurer Cancer Center, Hackensack, New Jersey 07601 United States
Local Institution - 0006, New York, New York 10032 United States
Local Institution - 0002, New York, New York 10065 United States
Providence Cancer Center Oncology and Hematology Care- Eastside, Portland, Oregon 97213 United States
Local Institution - 0063, Nashville, Tennessee 37204 United States
Vanderbilt University Medical Center, Nashville, Tennessee 37232 United States

Showing 10 of 47 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.