A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
About this study
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.
- Condition
- 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
- Tested
- BMS-986340, BMS-936558-01, Docetaxel, Pumitamig
- Sponsor
- Bristol-Myers Squibb
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: 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
- 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 12
- 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
47 sites, 39 recruiting
Blacktown Hospital
Blacktown, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Cabrini Hospital - Malvern
Malvern, Victoria, Australia
St Vincent's Hospital
Melbourne, Victoria, Australia
One Clinical Research
Nedlands, Western Australia, Australia
and 41 more sites on ClinicalTrials.gov
Contact
-
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286 Clinical.Trials@bms.com
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First line of the email MUST contain NCT # and Site #.
Potential match only. Final eligibility is determined by the study team.