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Recruiting Phase 1/2 NCT04895709

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

Phase 1/2 – combined early trial
Conditions: 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

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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 or docetaxel 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 participate
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, 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 9
Australia (1)
Blacktown Hospital
Blacktown , New South Wales
Adnan Nagrial, Site 0057
Canada (1)
Cross Cancer Institute
Edmonton , Alberta
Quincy Chu, Site 0027
China (1)
Local Institution - 0067
Beijing , Beijing Municipality
NOT_YET_RECRUITING
Germany (1)
Universitaetsklinikum Ulm
Ulm , Baden-Wurttemberg
Simon Laban, Site 0044
Israel (1)
Rabin Medical Center
Petah Tikva , Central District
Salomon Stemmer, Site 0036
Italy (1)
Humanitas
Rozzano , Milano
Matteo Simonelli, Site 0023
Japan (1)
National Cancer Center Hospital East
Kashiwa , Chiba
Yasutoshi Kuboki, Site 0064
Spain (1)
Hospital Universitario Virgen de la Victoria
Málaga , Andalusia
Javier Garcia Corbacho, Site 0048
United States (1)
Community Cancer Institute
Clovis , California
Uzair Chaudhary, Site 0032
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
27.05.2021
Completion date
07.07.2028
Registry ID
NCT04895709
Source
anzctr
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