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.
Who Can Participate?
Eligibility
- 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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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. Participants in this group will get the study drug, ZN-A-1041.
- Group 1b is for people with HER2-positive breast cancer. Participants in this group will get the study drug in combination with capecitabine
- Group 1c is for people with HER2-positive unresectable or metastatic breast cancer with brain metastases. Participants in this group will get the study drug in combination with capecitabine.
- 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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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 in Patients with HER2-Positive Advanced Solid Tumors
Principal Investigator
Carey
Anders
Protocol Number
PRO00105701
NCT ID
NCT05593094
Phase
I
Enrollment Status
Open to Enrollment