Study Summary
This trial is testing the safety and effectiveness of CGX1321, a new drug for solid tumors. The trial has two phases: Phase 1 is testing CGX1321 by itself and in combination with another cancer drug, while Phase 2 is testing CGX1321 in combination with two other cancer drugs.
- Gastrointestinal Cancer
- Solid Tumors
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 55 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
4 Treatment Groups
Arm 2: CGX1321 in combination with pembrolizumab dose escalation, dose expansion...
1 of 4
Arm 1: CGX1321 Single Agent dose escalation and dose expansion
1 of 4
CGX1321 alone and with pembrolizumab
1 of 4
Arm 3: CGX1321 in combination with encorafenib + cetuximab, dose escalation and ...
1 of 4
Experimental Treatment
72 Total Participants · 4 Treatment Groups
Primary Treatment: CGX1321 · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
What other experiments have incorporated CGX1321 as a component?
"CGX1321 was first scrutinized in 2010 by the City of Hope medical centre. To date, 347 associated studies have been completed and 961 are actively enrolling patients, with a large proportion conducted at Durham's facilities." - Anonymous Online Contributor
What therapeutic indications is CGX1321 regularly prescribed for?
"CGX1321 is the go-to treatment for malignant neoplasms and has proven to be efficacious in treating unresectable melanoma, microsatellite instability high, as well as disease progression following chemotherapy." - Anonymous Online Contributor
What is the scope of the participants in this medical experiment?
"The sponsor of this trial, Merck Sharp & Dohme LLC, will be managing the study at Duke Cancer Center in Durham and Gettysburg Cancer Center. In order to commence the research project 72 participants who meet the eligibility criteria must be recruited from these locations." - Anonymous Online Contributor
Has CGX1321 been officially sanctioned by the Food and Drug Administration?
"CGX1321 has only been tested on a small group of patients, so its safety rating stands at 1." - Anonymous Online Contributor
How many facilities are participating in this trial?
"This clinical experiment is taking place in 27 different sites, including the Duke Cancer Center and Duke University Medical Centre in Durham, North Carolina; Gettysburg Cancer Facility in Gettysburg, Pennsylvania; and CSNF Cancer Specialists of North Florida (QCCA) located in Jacksonville, Florida." - Anonymous Online Contributor
Is there room for additional participants in this experiment?
"Affirmative. Per the information published on clinicaltrials.gov, this medical trial is still recruiting participants and was initially posted to the platform on February 1st 2016. The study aims to enrol 72 individuals from 23 different sites across the country." - Anonymous Online Contributor