Zion (Solid Tumors) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out what the safest and most effective dose of the study drug (ZN-A-1041) is when given alone or in combination with Capecitabine.

What is the Condition Being Studied?

People with HER2-Positive Advanced Solid Tumors

Who Can Participate in the Study?

Phase 1a - Adults with HER2-positive advanced solid tumors
Phase 1b - Adults with HER2-positive breast cancer
Phase 1c - Adults with HER2-positive unresectable or metastatic breast cancer with brain metastases

Age Group
Adults

What is Involved?

This study will consist of three groups, Group 1a, Group 1b, and Group 1c.

Group 1a is for people with HER2-positive advanced solid tumors and will get the study drug, ZN-A-1041

Group 1b is for people with HER2-positive breast cancer and will get the study drug in combination with Capecitabine

Group 1c if for people with HER2-positive unresectable or metastatic breast cancer with brain metastases and will get the study drug in combination with Capecitabine

If you choose to join this study you will:
-Complete a 28 day screening period
-Complete a 21 day period where you take the study drug twice a day
-Have physical exams, blood and urine tests
-Have an eye exam
-Have imaging scans (CT and/or MRI)
-Complete a follow-up 28 days after finishing the study drug

You will be in the study until your disease progresses or you're unable to tolerate the study drug(s).

Study Details

Full Title
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination with Capecitabine Tablets in Patients with HER2-Positive Advanced Solid Tumors
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00105701
NCT: NCT04487236
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698