D3-002: A Study to Evaluate ETC-1922159 in Advanced Solid Tumors
What is the Purpose of this Study?
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
- 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
What is the Condition Being Studied?
Metastatic Colorectal Cancer, Ovarian Cancer, Endometrial Cancer
Who Can Participate in this 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
Adults
Participating Institutions
What is Involved?
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.
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
Protocol Number
IRB:
PRO00103906
NCT:
NCT02521844
ClinicalTrials.gov
View on ClinicalTrials.gov