D3-002: A Study to Evaluate ETC-1922159 in Advanced Solid Tumors - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about how an experimental drug (ETC-1922159) works in your body and against your cancer. We will compare how this drug works on its own or in combination with a drug called pembrolizumab.

What is the Condition Being Studied?

Metastatic Colorectal Cancer, Ovarian Cancer, Endometrial Cancer

Who Can Participate in the Study?

Adults ages 18 and older who:
- Are diagnosed with advanced or metastatic tumors that cannot be removed and do not respond to standard treatments
- Have not received radiation to the spine/pelvis bone or chemoradiation to pelvic organs
- Do not have osteoporosis or metastases to the bone

Age Group

What is Involved?

If you choose to join this study, you will:
- Go through a screening period to see if you're eligible for the study
- Have a tumor biopsy done, if necessary

If you're eligible to join, you will:
- Have physical exams
- Give blood samples
- Have other tests done during your clinic visits
- Be placed into 1 of 2 groups depending on when you join the study
-- One group will get the study drug (ETC-1922159) alone and start the combination of study drug and pembrolizumab if the cancer starts to grow
-- The other group will get the study drug in combination with pembrolizumab from the start of the study
--- ETC-1922159 is a capsule taken by mouth every other day
--- Pembrolizumab is given in the clinic by IV once every 3 weeks

Study Details

Full Title
[D3-002] A phase 1A/B study to evaluate the safety and tolerability of ETC-1922159 as a single agent and in combination with pembrolizumab in advanced solid tumours
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00103906
NCT: NCT02521844
Phase I/II
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center