Spots Global Cancer Trial Database for A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal Malignancies
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Trial Identification
Brief Title: A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal Malignancies
Official Title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Gastrointestinal Malignancies
Study ID: NCT03720678
Study Description
Brief Summary: This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with mFOLFOX in participants with advanced metastatic gastroesophageal Cancer (GEC) or colorectal cancer (CRC).
Detailed Description: In the dose escalation phase, escalating doses of etrumadenant in combination with mFOLFOX at standard doses will be assessed in participants with advanced metastatic GEC or CRC. Eligible participants will receive oral administration of etrumadenant as well as IV infusion of mFOLFOX. The recommended dose for expansion (RDE) of etrumadenant will be determined upon completion of the dose-escalation phase. In the dose expansion phase, etrumadenant at the RDE in combination with mFOLFOX at standard doses may be assessed in participants with advanced metastatic GEC or CRC. Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Clinical Research Center, Tucson, Arizona, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Maryland Oncology Hematology, Rockville, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
QUEST Research Institute, Farmington Hills, Michigan, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Carolina BioOncology Institute, Huntersville, North Carolina, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Prisma Health, Greenville, South Carolina, United States
Texas Oncology - Austin Midtown, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Fort Worth Cancer Center, Fort Worth, Texas, United States
Texas Oncology - San Antonio Northeast, San Antonio, Texas, United States
Texas Oncology - San Antonio Medical Center, San Antonio, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Border Medical Oncology, Albury, New South Wales, Australia
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
The Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia
St. George Private Hospital, Kogarah, New South Wales, Australia
Macquarie University Hospital, Macquarie Park, New South Wales, Australia
Peninsula & South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
Cabrini Hospital, Malvern, Victoria, Australia
Contact Details
Name: Medical Director
Affiliation: Arcus Biosciences, Inc.
Role: STUDY_DIRECTOR
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