Safety and efficacy of CGX1321 for advanced tumors - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drug, CGX1321, is safe and effective for fighting cancer.

What is the Condition Being Studied?

Gastrointestinal Cancer

Who Can Participate in the Study?

Adults with advanced gastrointestinal cancer who:
-Failed, refused, or are unsuited for standard-of-care treatment

Age Group

What is Involved?

If you choose to join this study, you will:
-Take the study drug, CGX1321, by mouth once a day
-Take zoledronic acid by I.V. once every 6 or 8 weeks
-Take daily supplements of vitamin D3 and calcium carbonate
-Give blood and urine samples
-Have regular CT or MRI scans

In addition, some people may also get pembrolizumab by I.V. once every 3 weeks.

Study Details

Full Title
[CGX1321-101] A Phase 1 Open-label Dose Escalation and Dose Expansion Study of CGX1321 in Subjects with Advanced Solid Tumors and Phase 1b Study of CGX1321 in Combination with Pembrolizumab in Subjects with Advanced Gastrointestinal Tumors
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00102442
NCT: NCT02675946
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center