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Recruiting Phase 1/2

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

NCT04895709 · tracked via the Priya Life Science Italy tracker
Phase
Phase 1/2
Started
2021-05-27
Last updated
2026-08-17

Condition(s) studied

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

Investigational drug(s) / intervention(s)

BMS-986340 →BMS-936558-01 →Docetaxel →Pumitamig →

BMS-986340: Specified dose on specified days

BMS-936558-01: Specified dose on specified days

Docetaxel: Specified dose on specified days

Pumitamig: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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

Trial sites (47)

FacilityCityRegionStatus
Community Cancer Institute Clovis California Recruiting
USC/Norris Comprehensive Cancer Center Los Angeles California Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
University of Iowa Iowa City Iowa Recruiting
John Theurer Cancer Center Hackensack New Jersey Recruiting
Local Institution - 0006 New York New York Completed
Local Institution - 0002 New York New York Completed
Providence Cancer Center Oncology and Hematology Care- Eastside Portland Oregon Recruiting
Local Institution - 0063 Nashville Tennessee Withdrawn
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Houston Methodist Hospital Houston Texas Recruiting
Blacktown Hospital Blacktown New South Wales Recruiting
Liverpool Hospital Liverpool New South Wales Recruiting
Princess Alexandra Hospital Brisbane Queensland Recruiting
Cabrini Hospital - Malvern Malvern Victoria Recruiting
St Vincent's Hospital Melbourne Victoria Recruiting
One Clinical Research Nedlands Western Australia Recruiting
Cross Cancer Institute Edmonton Alberta Recruiting
Local Institution - 0030 Vancouver British Columbia Completed
Hamilton Health Sciences-Juravinski Cancer Centre Hamilton Ontario Recruiting
Local Institution - 0009 Toronto Ontario Completed
Centre Hospitalier de luniversite de Montreal Montreal Quebec Recruiting
Local Institution - 0016 Ottawa Canada Completed
Local Institution - 0044 Ulm Baden-Wurttemberg Completed
Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit Dresden Germany Recruiting
Universitaetsklinikum Essen Essen Germany Recruiting
Universitatsklinikum Frankfurt Frankfurt Germany Recruiting
Universitaetsklinikum Wuerzburg Würzburg Germany Recruiting
Rabin Medical Center Petah Tikva Central District Recruiting
Local Institution - 0035 Ramat Gan Central District Withdrawn
Sheba Medical Center Ramat Gan Central District Recruiting
Rambam Health Care Campus Haifa Northern District Recruiting
Sourasky Medical Center Tel Aviv Tell Abīb Recruiting
Humanitas Rozzano Milano Recruiting
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia Candiolo Torino Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 Milan Italy Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale Naples Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Roma Italy Recruiting
ospedale le scotte-U.O.C. Immunoterapia Oncologica Siena Italy Recruiting
National Cancer Center Hospital East Kashiwa Chiba Recruiting

+ 7 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04895709 on ClinicalTrials.gov ↗ ← All trials in Italy