A Phase I/II Study of 7MW4911 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With Advanced Colorectal Cancer and Other Advanced Gastrointestinal Tumors
Summary
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
Arms & interventions
- Drug7MW4911
study drug
Outcome measures
Primary
Incidence and rates of adverse events
To assess the safety and tolerability of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors
Time frame: Up to approximately 2 years
MTD, RED, and RP2D
To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D)
Time frame: Up to approximately 2 years
Secondary
Tmax of 7MW4911
Time frame: up to 3 months
Cmax of 7MW4911
Time frame: up to 3 months
Half life of 7MW4911
Time frame: up to 3 months
Area under the curve of 7MW4911
Time frame: up to 3 months
Objective response rate
Time frame: Up to approximately 2 years
Progression-free survival
Time frame: up to approximately 2 years
Immunogenicity of 7MW4911
Time frame: Up to approximately 2 years
Eligibility criteria
Study locations (5)
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Massachusetts General Hospital
Boston, Massachusetts, 02114
START
Long Island City, New York, 11042
START Moutain Region
West Valley City, Utah, 84119
Fred Hutchinson Cancer Center
Seattle, Washington, 98109