Back to Trials
NCT04895709PHASE1, PHASE2Recruiting

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

Bristol-Myers Squibb

Start Date

5/27/2021

Completion Date

8/31/2031

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, 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BMS-986340

DRUG

BMS-936558-01

DRUG

Docetaxel

DRUG

Pumitamig

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Cervical CancerGastric/Gastroesophageal Junction AdenocarcinomaMicrosatellite Stable Colorectal CancerNon-Small-Cell Lung CancerSquamous Cell Carcinoma of Head and NeckCarcinoma, Renal CellUrothelial CarcinomaPancreatic AdenocarcinomaMelanomaOvarian NeoplasmsTriple Negative Breast Neoplasms

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 37067

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Blacktown Hospital

Blacktown, New South Wales 2148

Australia

Liverpool Hospital

Liverpool, New South Wales 2170

Australia

Princess Alexandra Hospital

Brisbane, Queensland 4102

Australia

Cabrini Hospital - Malvern

Malvern, Victoria 3144

Australia

St Vincent's Hospital

Melbourne, Victoria 3065

Australia

One Clinical Research

Nedlands, Western Australia 6009

Australia

Cross Cancer Institute

Edmonton, Alberta T6X 1E8

Canada

Local Institution - 0030

Vancouver, British Columbia V5Z 4E6

Canada

Hamilton Health Sciences-Juravinski Cancer Centre

Hamilton, Ontario L8V5C2

Canada

Local Institution - 0009

Toronto, Ontario M5G 2M9

Canada

Centre Hospitalier de luniversite de Montreal

Montreal, Quebec H2X 0A9

Canada

Local Institution - 0016

Ottawa, K1H 8L6

Canada

Local Institution - 0044

Ulm, Baden-Wurttemberg 89081

Germany

Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit

Dresden, 01307

Germany

Universitaetsklinikum Essen

Essen, 45147

Germany

Universitatsklinikum Frankfurt

Frankfurt, 60590

Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97078

Germany

Rabin Medical Center

Petah Tikva, Central District 4941492

Israel

Local Institution - 0035

Ramat Gan, Central District 5265601

Israel

Sheba Medical Center

Ramat Gan, Central District 5265601

Israel

Rambam Health Care Campus

Haifa, Northern District 3109601

Israel

Sourasky Medical Center

Tel Aviv, Tell Abīb 6423906

Israel

Humanitas

Rozzano, Milano 20089

Italy

Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

Candiolo, Torino 10060

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1

Milan, 20133

Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, 80131

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, 00168

Italy

ospedale le scotte-U.O.C. Immunoterapia Oncologica

Siena, 53100

Italy

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia 29010

Spain

Institut Catalan d Oncologia (ICO) - Badalona

Badalona, Barcelona [Barcelona] 08916

Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona] 08035

Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de 28041

Spain

Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD

Madrid, 28040

Spain

Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC

Madrid, 28050

Spain

Clinica Universidad de Navarra-oNCOLOGY

Pamplona, 31008

Spain