NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

RecruitingPhase 1, Phase 2

Sponsor: Bristol-Myers Squibb

Conditions: Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck

Interventions: BMS-986340, BMS-936558-01, Docetaxel, Pumitamig

Countries: United States, Australia, Canada, Germany, Israel, Italy, Japan, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (47)

Clovis, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Iowa City, Iowa, United States
Hackensack, New Jersey, United States
New York, New York, United States
New York, New York, United States
Portland, Oregon, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Blacktown, New South Wales, Australia
Liverpool, New South Wales, Australia
Brisbane, Queensland, Australia
Malvern, Victoria, Australia
Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Ottawa, Canada
Ulm, Baden-Wurttemberg, Germany
Dresden, Germany
Essen, Germany
Frankfurt, Germany
Würzburg, Germany
Petah Tikva, Central District, Israel
Ramat Gan, Central District, Israel
+ 17 more on CT.gov