Tucatinib, trastuzumab, and either oxaliplatin or pembrolizumab for HER2+ GI cancers - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drug, tucatinib, is safe and effective to use with trastuzumab plus oxaliplatin-based chemotherapy and/or pembrolizumab. We also want to find the best dose of tucatinib to use to shrink the cancer.

What is the Condition Being Studied?

HER2+ Gastrointestinal Cancer

Who Can Participate in the Study?

Adults with HER2+ cancer and one of the following tumor types:
-Colorectal carcinoma (cancer of the colon or rectum)
-Gastric adenocarcinoma (a type of stomach cancer)
-Esophageal adenocarcinoma (a type of cancer in the esophagus)
-Gastroesophageal junction adenocarcinoma (a type of cancer that occurs where the esophagus meets the stomach)
-Cholangiocarcinoma (cancer of the bile ducts)
-Gallbladder carcinoma (cancer of the gallbladder)

Age Group

What is Involved?

If you choose to join this study, you will:
- Take the study drug, tucatinib, by mouth twice a day
- Get trastuzumab every 2 or 3 weeks
- Get chemotherapy and/or pembrolizumab every 2 or 3 weeks
- Give blood and urine samples
- Have regular CT or MRI scans

Study Details

Full Title
[SGNTUC-024] A phase 1b/2 dose escalation and expansion study of tucatinib in combination with trastuzumab and oxaliplatin-based chemotherapy or pembrolizumab-containing combinations for HER2+ gastrointestinal cancers
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00105789
NCT: NCT04430738
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center