NCT04895709RecruitingPhase 1/2
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 1109 (estimated)
- First submitted
- 19 May 2021
- Start date
- 27 May 2021
- Primary completion date
- 31 Aug 2031
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Melanoma, Bladder cancer, Kidney cancer, Head and neck cancer, Cervical cancer, Triple-negative breast cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT04895709
- EudraCT number
- 2023-503651-10
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 1109
- From 27 May 2021 to the primary completion date, 31 Aug 2031
- 47 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Major surgery within 4 weeks of study drug administration.
Other illness
- Primary central nervous system (CNS) malignancy.
- 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.
- Uncontrolled or significant cardiovascular disease.
- History of or with active interstitial lung disease or pulmonary fibrosis.
Other
- Women who are pregnant or breastfeeding.
- Untreated CNS metastases.
- Leptomeningeal metastases.
- Other protocol-defined inclusion/exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blacktown Hospital Coordinator of this site? Confirm its status | Blacktown | Australia | Recruiting |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Recruiting |
| Cabrini Hospital - Malvern Coordinator of this site? Confirm its status | Malvern | Australia | Recruiting |
| St Vincent's Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| One Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Hamilton Health Sciences-Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Centre Hospitalier de luniversite de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Ottawa | Canada | Completed |
| Local Institution - 0009 Coordinator of this site? Confirm its status | Toronto | Canada | Completed |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Vancouver | Canada | Completed |
| Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaetsklinikum - Essen Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitätsklinikum Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Ulm | Germany | Completed |
| Universitaetsklinikum Wuerzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Recruiting |
| Institut Catalan d Oncologia (ICO) - Badalona Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Clinica Universidad de Navarra-oNCOLOGY Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Withdrawn |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia Coordinator of this site? Confirm its status | Candiolo | Italy | Recruiting |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| ospedale le scotte-U.O.C. Immunoterapia Oncologica Coordinator of this site? Confirm its status | Siena | Italy | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Community Cancer Institute Coordinator of this site? Confirm its status | Clovis | United States | Recruiting |
| John Theurer Cancer Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Nashville | United States | Withdrawn |
| Hoag Memorial Hospital Presbyterian Coordinator of this site? Confirm its status | Newport Beach | United States | Recruiting |
| Local Institution - 0006 Coordinator of this site? Confirm its status | New York | United States | Completed |
| Local Institution - 0002 Coordinator of this site? Confirm its status | New York | United States | Completed |
| Providence Cancer Center Oncology and Hematology Care- Eastside Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.