A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms, Triple Negative Breast Neoplasms
In brief
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.
Key facts
- Study ID
- NCT04895709
- Run by
- Bristol-Myers Squibb
- People needed
- 1109
- Starts
- 2021-05-27
- Expected to finish
- 2031-08-31
- Last updated by the study team
- 2026-06-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Community Cancer Institute — Clovis, California, United States (enrolling)
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
- University of Iowa — Iowa City, Iowa, United States (enrolling)
- John Theurer Cancer Center — Hackensack, New Jersey, United States (enrolling)
- National Cancer Center Hospital East — Kashiwa, Chiba, Japan (enrolling)
- Hospital Universitario Virgen de la Victoria — Málaga, Andalusia, Spain (enrolling)
- Institut Catalan d Oncologia (ICO) - Badalona — Badalona, Barcelona [Barcelona], Spain (enrolling)
- Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [Barcelona], Spain (enrolling)
- Hospital Universitario 12 de Octubre — Madrid, Madrid, Comunidad de, Spain (enrolling)
- Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD — Madrid, Spain (enrolling)
- Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC — Madrid, Spain (enrolling)
- Clinica Universidad de Navarra-oNCOLOGY — Pamplona, Spain (enrolling)
- Providence Cancer Center Oncology and Hematology Care- Eastside — Portland, Oregon, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
- Blacktown Hospital — Blacktown, New South Wales, Australia (enrolling)
- Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (enrolling)
- Cabrini Hospital - Malvern — Malvern, Victoria, Australia (enrolling)
- St Vincent's Hospital — Melbourne, Victoria, Australia (enrolling)
- One Clinical Research — Nedlands, Western Australia, Australia (enrolling)
- Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)
- Hamilton Health Sciences-Juravinski Cancer Centre — Hamilton, Ontario, Canada (enrolling)
- Centre Hospitalier de luniversite de Montreal — Montreal, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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