CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)
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ClinicalTrials.gov Identifier: NCT02675946 |
Recruitment Status : Unknown
Verified January 2022 by Curegenix Inc..
Recruitment status was: Recruiting
First Posted : February 5, 2016
Last Update Posted : January 26, 2022
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Tracking Information | |||
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First Submitted Date ICMJE | January 22, 2016 | ||
First Posted Date ICMJE | February 5, 2016 | ||
Last Update Posted Date | January 26, 2022 | ||
Actual Study Start Date ICMJE | February 2016 | ||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Number of participants with adverse events and/or abnormal laboratory values that are related to treatment [ Time Frame: 55 months ] safety
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Original Primary Outcome Measures ICMJE |
Number of participants with adverse events and/or abnormal laboratory values that are related to treatment [ Time Frame: 28 months ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596) | ||
Official Title ICMJE | 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 | ||
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) |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Enrollment to Single Agent Dose Expansion, Roll-over Cohort, Phase 1b CGX1321-101 in combination with pembrolizumab dose expansion and Phase 1b CGX1321 in combination with encorafenib + cetuximab dose escalation and dose expansion Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Estimated Enrollment ICMJE |
72 | ||
Original Estimated Enrollment ICMJE |
86 | ||
Estimated Study Completion Date ICMJE | March 2023 | ||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria The following criteria must be met by ALL subjects
In addition, the following criteria must be met based on the group to be enrolled into: For subjects in the Phase 1 Single Agent CGX1321 Dose Escalation phase:
For subjects in the Phase 1 Single Agent CGX1321 Dose Expansion phase:
For subjects in the Phase 1b or Roll-over Cohort CGX1321 in combination with pembrolizumab:
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of pembrolizumab through 120 days after the last dose of pembrolizumab Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject For subjects in the Phase 1b Cohort CGX1321 in Combination with Encorafenib + Cetuximab:
All subjects must be excluded from participating in the study if subjects meet any of the following criteria:
In addition, subjects must be excluded from participating if they meet any of the following criteria based on the group to be enrolled into: For subjects in the Phase 1 Single Agent CGX1321 Dose Escalation or Dose Expansion phase: 1. Known active hepatitis A, B or C Note: Subjects who are HBsAg+ and have DNA load < 2000 IU/mL (104 copies/mL) are eligible to participate in the Phase 1 study For subjects in the Phase 1b or Roll-over Cohort CGX1321 in combination with pembrolizumab:
For subjects in the Phase 1b Cohort CGX1321 in Combination with Encorafenib + Cetuximab:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Taiwan, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02675946 | ||
Other Study ID Numbers ICMJE | CGX1321-101 MK3475-596 ( Other Identifier: Merck, Sharpe and Dohme Corporation ) |
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Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Curegenix Inc. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Curegenix Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Merck Sharp & Dohme LLC | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Curegenix Inc. | ||
Verification Date | January 2022 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |