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
Grupo etario
Adultos
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. 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.
Si elige unirse a este estudio, podrá:
- 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 in Patients with HER2-Positive Advanced Solid Tumors
Principal Investigator
Especialista en oncología médica
Protocol Number
IRB:
PRO00105701
NCT:
NCT05593094
Phase
Fase I
ClinicalTrials.gov
View on ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción