A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Recruiting · NCT04895709 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 7 US states.
- Community Cancer Institute - Clovis, California, United States
- Community Cancer Institute - Clovis, California, United States
- USC/Norris Comprehensive Cancer Center - Los Angeles, California, United States
- USC/Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Hoag Memorial Hospital Presbyterian - Newport Beach, California, United States
- Hoag Memorial Hospital Presbyterian - Newport Beach, California, United States
- University of Iowa - Iowa City, Iowa, United States
- University of Iowa - Iowa City, Iowa, United States
- John Theurer Cancer Center - Hackensack, New Jersey, United States
- John Theurer Cancer Center - Hackensack, New Jersey, United States
- Local Institution - 0006 - New York, New York, United States
- Local Institution - 0002 - New York, New York, United States
- Local Institution - 0006 - New York, New York, United States
- Local Institution - 0002 - New York, New York, United States
- Providence Cancer Center Oncology and Hematology Care- Eastside - Portland, Oregon, United States
- Providence Cancer Center Oncology and Hematology Care- Eastside - Portland, Oregon, United States
- Local Institution - 0063 - Nashville, Tennessee, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Local Institution - 0063 - Nashville, Tennessee, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Houston Methodist Hospital - Houston, Texas, United States
- Houston Methodist Hospital - Houston, Texas, United States
- Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit - Dresden, Germany
- Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit - Dresden, Germany
- Universitaetsklinikum Essen - Essen, Germany
- Universitaetsklinikum Essen - Essen, Germany
- Universitatsklinikum Frankfurt - Frankfurt, Germany
- Universitatsklinikum Frankfurt - Frankfurt, Germany
- Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD - Madrid, Spain
- Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC - Madrid, Spain
- Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD - Madrid, Spain
- Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC - Madrid, Spain
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 - Milan, Italy
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 - Milan, Italy
- Istituto Nazionale Tumori IRCCS Fondazione Pascale - Naples, Italy
- Istituto Nazionale Tumori IRCCS Fondazione Pascale - Naples, Italy
- Local Institution - 0016 - Ottawa, Canada
- Local Institution - 0016 - Ottawa, Canada
- Clinica Universidad de Navarra-oNCOLOGY - Pamplona, Spain
- Clinica Universidad de Navarra-oNCOLOGY - Pamplona, Spain
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore - Roma, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore - Roma, Italy
- ospedale le scotte-U.O.C. Immunoterapia Oncologica - Siena, Italy
- ospedale le scotte-U.O.C. Immunoterapia Oncologica - Siena, Italy
- Universitaetsklinikum Wuerzburg - Würzburg, Germany
- Universitaetsklinikum Wuerzburg - Würzburg, Germany
- Cross Cancer Institute - Edmonton, Alberta, Canada
- Cross Cancer Institute - Edmonton, Alberta, Canada
- Hospital Universitario Virgen de la Victoria - Málaga, Andalusia, Spain
- Hospital Universitario Virgen de la Victoria - Málaga, Andalusia, Spain
- Local Institution - 0044 - Ulm, Baden-Wurttemberg, Germany
- Local Institution - 0044 - Ulm, Baden-Wurttemberg, Germany
- Institut Catalan d Oncologia (ICO) - Badalona - Badalona, Barcelona [Barcelona], Spain
- Institut Catalan d Oncologia (ICO) - Badalona - Badalona, Barcelona [Barcelona], Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Barcelona [Barcelona], Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Barcelona [Barcelona], Spain
- Local Institution - 0030 - Vancouver, British Columbia, Canada
- Local Institution - 0030 - Vancouver, British Columbia, Canada
- Rabin Medical Center - Petah Tikva, Central District, Israel
- Rabin Medical Center - Petah Tikva, Central District, Israel
Showing 60 of 94 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →