Spots Global Cancer Trial Database for CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)
Official Title: A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Solid Tumors With Expansion in Advanced Gastrointestinal Tumors and Phase 1b Study of CGX1321 in Combination With Pembrolizumab in Subjects With Advanced Colorectal Cancer or in Combination With Encorafenib + Cetuximab in Subjects With BRAFV600E Mutated Advanced Colorectal Cancer
Study ID: NCT02675946
Study Description
Brief Summary: 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.
Detailed Description: The purpose of the Dose Escalation Phase is to examine the safety and determine the maximum tolerated dose of CGX1321 when administered to subjects with advanced solid tumors. The purpose of the Dose Expansion Phase, Roll-over Cohort and Phase 1b is to continue to examine the safety and confirm the final Phase 2 dose of CGX1321 alone in subjects with advanced GI tumors (Dose Expansion Phase) and evaluate the safety and tolerability of CGX1321 in combination with pembrolizumab (Phase 1b and Roll-over Cohort) and of CGX1321 in combination with encorafenib + cetuxumab (Phase 1b)
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Memorial Care, Long Beach, California, United States
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
Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
, Brooksville, Florida, United States
CSNF Cancer Specialists of North Florida (QCCA), Jacksonville, Florida, United States
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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Nebraska Cancer Specialists (QCCA), Omaha, Nebraska, United States
Summit Medical Group, Florham Park, New Jersey, United States
Duke Cancer Center, Duke University Medical Center, Durham, North Carolina, 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
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Taipei Medical University Hospital, Taipei, , Taiwan
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
