CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)
Status unconfirmed · Phase 1
Conditions studied: Solid Tumors, GI Cancer
In brief
This is a multicenter, open-label study conducted in two phases: Phase 1 consisting of a CGX1321 Single Agent Dose Escalation Phase in solid tumors, CGX1321 Single Agent Dose Expansion Phase in GI tumors and Roll-over Cohort of CGX1321 and pembrolizumab in subjects who have progressed on single agent CGX1321 and Phase 1b consisting of CGX1321 in combination with pembrolizumab in colorectal tumors and CGX1321 in combination with encorafenib + cetuximab in BRAFV600E mutated colorectal tumors. Both phases are to evaluate safety, pharmacokinetics, and clinical activity.
Key facts
- Study ID
- NCT02675946
- Run by
- Curegenix Inc.
- People needed
- 72
- Starts
- 2016-02-01
- Expected to finish
- 2023-03-01
- Last updated by the study team
- 2022-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States (enrolling)
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (enrolling)
- Duke Cancer Center, Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Ocala Oncology — Ocala, Florida, United States
- University Cancer & Blood Center (QCCA) — Athens, Georgia, United States
- Hawaii Cancer Center — Honolulu, Hawaii, United States
- Edward H. Kaplan MD and Associates — Skokie, Illinois, United States
- Goshen Health — Goshen, Indiana, United States
- Community Health Network — Indianapolis, Indiana, United States
- Nebraska Cancer Specialists (QCCA) — Omaha, Nebraska, United States
- Summit Medical Group — Florham Park, New Jersey, United States
- Gettysburg Cancer Center — Gettysburg, Pennsylvania, United States
- Sanford Health — Sioux Falls, South Dakota, United States
- Baptist Cancer Center — Memphis, Tennessee, United States
- START (South Texas Accelerated Research Therapeutics, LLC) — San Antonio, Texas, United States
- Northwest Medical Specialists (QCCA) — Tacoma, Washington, United States
- Memorial Care — Long Beach, California, United States
- Taipei Medical University Hospital — Taipei, Taiwan
- St. Joseph's Santa Rosa — Santa Rosa, California, United States
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
- Hartford Health Care — Hartford, Connecticut, United States
- Study site — Brooksville, Florida, United States
Full record on ClinicalTrials.gov
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