Spots Global Cancer Trial Database for Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies
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Trial Identification
Brief Title: Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies
Official Title: A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous Zotatifin (eFT226) in Subjects With Selected Advanced Solid Tumor Malignancies
Study ID: NCT04092673
Conditions
Study Description
Brief Summary: This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of Zotatifin (eFT226) in subjects with selected advanced solid tumor malignancies.
Detailed Description: Part 1 (Dose Escalation): Completed; Recommended Phase 2 Dose (RP2D) and Maximum Tolerated Dose (MTD) identified Part 1a (Dose Escalation) This cohort will enroll patients with an advanced breast cancer that is refractory or intolerant to SOC therapy. Part 1b (Dose Escalation) This cohort will enroll patients with an advanced breast cancer that is refractory or intolerant to SOC therapy. Part 2 (Expansion Cohort) provides defined expansion cohorts to further explore the safety, pharmacology, and clinical activity of eFT226 monotherapy and in various combinations in subjects with previously treated advanced solid tumor malignancies.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Southern California, Los Angeles, California, United States
Valkyrie Clinical Trials, Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Stanford University, Palo Alto, California, United States
START Midwest, Grand Rapids, Michigan, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Memorial Sloan Kettering Cancer Center- Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Commack, Commack, New York, United States
Memorial Sloan Kettering Cancer Center- Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center- David H. Koch Center for Cancer Care, New York, New York, United States
University of Toledo Medical Center, Toledo, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
New Experimental Therapeutics of San Antonio - NEXT Oncology, San Antonio, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Contact Details
Name: Douglas Warner, MD
Affiliation: EFFECTOR Therapeutics, Inc.
Role: STUDY_DIRECTOR
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