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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
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

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Blacktown Hospital
Coordinator of this site? Confirm its status
BlacktownAustraliaRecruiting
Princess Alexandra Hospital
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BrisbaneAustraliaRecruiting
Liverpool Hospital
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LiverpoolAustraliaRecruiting
Cabrini Hospital - Malvern
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MalvernAustraliaRecruiting
St Vincent's Hospital
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MelbourneAustraliaRecruiting
One Clinical Research
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NedlandsAustraliaRecruiting
Cross Cancer Institute
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EdmontonCanadaRecruiting
Hamilton Health Sciences-Juravinski Cancer Centre
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HamiltonCanadaRecruiting
Centre Hospitalier de luniversite de Montreal
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MontrealCanadaRecruiting
Local Institution - 0016
Coordinator of this site? Confirm its status
OttawaCanadaCompleted
Local Institution - 0009
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TorontoCanadaCompleted
Local Institution - 0030
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VancouverCanadaCompleted
Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit
Coordinator of this site? Confirm its status
DresdenGermanyRecruiting
Universitaetsklinikum - Essen
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EssenGermanyRecruiting
Universitätsklinikum Frankfurt
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FrankfurtGermanyRecruiting
Local Institution - 0044
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UlmGermanyCompleted
Universitaetsklinikum Wuerzburg
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WürzburgGermanyRecruiting
Institut Catalan d Oncologia (ICO) - Badalona
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BadalonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Clinica Universidad de Navarra-oNCOLOGY
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PamplonaSpainRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Local Institution - 0035
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Ramat GanIsraelWithdrawn
Sourasky Medical Center
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Tel AvivIsraelRecruiting
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
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CandioloItalyRecruiting
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
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MilanItalyRecruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale
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NaplesItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
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RomaItalyRecruiting
Humanitas
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RozzanoItalyRecruiting
ospedale le scotte-U.O.C. Immunoterapia Oncologica
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SienaItalyRecruiting
National Cancer Center Hospital East
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KashiwaJapanRecruiting
Community Cancer Institute
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ClovisUnited StatesRecruiting
John Theurer Cancer Center
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HackensackUnited StatesRecruiting
Houston Methodist Hospital
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HoustonUnited StatesRecruiting
University of Iowa
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Iowa CityUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesRecruiting
Vanderbilt University Medical Center
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NashvilleUnited StatesRecruiting
Local Institution - 0063
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NashvilleUnited StatesWithdrawn
Hoag Memorial Hospital Presbyterian
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Newport BeachUnited StatesRecruiting
Local Institution - 0006
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New YorkUnited StatesCompleted
Local Institution - 0002
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New YorkUnited StatesCompleted
Providence Cancer Center Oncology and Hematology Care- Eastside
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.