CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)
- Conditions
- Solid TumorsGI Cancer
- Interventions
- Registration Number
- NCT02675946
- Lead Sponsor
- Curegenix Inc.
- 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: CGX1321 Single Agent dose escalation and dose expansion CGX1321 Arm 1: Dose Escalation Phase: Ascending doses of CGX1321 once daily, orally, for 3 weeks (21 days) followed by a one-week (7-day) washout period in each 28-day cycle Dose Expansion Phase: CGX1321, at the MTD (identified in the Dose Escalation Phase), once daily, orally, for 3 weeks (21 days) followed by a one-week (7-day) washout period in each 28-day cycle. Arm 2: CGX1321 in combination with pembrolizumab dose escalation, dose expansion and Roll-over, CGX1321 Arm 2: Roll-over Cohort: CGX1321 at a dose identified in Phase 1b, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle). Arm 2: Phase 1b: Ascending doses of CGX1321, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle). Arm 3: CGX1321 in combination with encorafenib + cetuximab, dose escalation and dose expansion CGX1321 Arm 3: Phase 1b: Ascending doses of CGX1321, once daily, orally for 3 weeks (21 days) followed by a one-week (7 day) washout period in combination with enocrafenib administered orally once daily and cetuximab administered IV once weekly Arm 3: CGX1321 in combination with encorafenib + cetuximab, dose escalation and dose expansion encorafenib Arm 3: Phase 1b: Ascending doses of CGX1321, once daily, orally for 3 weeks (21 days) followed by a one-week (7 day) washout period in combination with enocrafenib administered orally once daily and cetuximab administered IV once weekly Arm 2: CGX1321 in combination with pembrolizumab dose escalation, dose expansion and Roll-over, Pembrolizumab Arm 2: Roll-over Cohort: CGX1321 at a dose identified in Phase 1b, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle). Arm 2: Phase 1b: Ascending doses of CGX1321, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle). Arm 3: CGX1321 in combination with encorafenib + cetuximab, dose escalation and dose expansion cetuximab Arm 3: Phase 1b: Ascending doses of CGX1321, once daily, orally for 3 weeks (21 days) followed by a one-week (7 day) washout period in combination with enocrafenib administered orally once daily and cetuximab administered IV once weekly
- Primary Outcome Measures
Name Time Method Number of participants with adverse events and/or abnormal laboratory values that are related to treatment 55 months safety
- Secondary Outcome Measures
Name Time Method CGX1321 half-life 30 Days pharmacokinetics
CGX1321 minimum or trough concentration 30 Days pharmacokinetics
CGX1321 time to maximum concentration 30 Days pharmacokinetics
CGX1321 area under the curve 30 Days pharmacokinetics
CGX1321 maximum or peak concentration 30 Days pharmacokinetics
Trial Locations
- Locations (25)
Edward H. Kaplan MD and Associates
🇺🇸Skokie, Illinois, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Memorial Care
🇺🇸Long Beach, California, United States
Hartford Health Care
🇺🇸Hartford, Connecticut, United States
Sanford Health
🇺🇸Sioux Falls, South Dakota, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
St. Joseph's Santa Rosa
🇺🇸Santa Rosa, California, United States
Sarah Cannon Research Institute at HealthONE
🇺🇸Denver, Colorado, United States
CSNF Cancer Specialists of North Florida (QCCA)
🇺🇸Jacksonville, Florida, United States
University Cancer & Blood Center (QCCA)
🇺🇸Athens, Georgia, United States
Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
Ocala Oncology
🇺🇸Ocala, Florida, 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
Nebraska Cancer Specialists (QCCA)
🇺🇸Omaha, Nebraska, United States
Duke Cancer Center, Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Gettysburg Cancer Center
🇺🇸Gettysburg, Pennsylvania, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, 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
Hawaii Cancer Center
🇺🇸Honolulu, Hawaii, United States