Phase 1 Study of ZN-A-1041 for HER2-Positive Advanced Solid Tumors
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT05593094
This clinical trial is testing the safety and effectiveness of a new drug, ZN-A-1041, for treating advanced solid tumors that are HER2-positive. The study will explore how well the drug works alone and in combination with other treatments, including in patients with brain metastases.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is investigating a new treatment called ZN-A-1041 for patients with advanced solid tumors that are HER2-positive. The trial is divided into three parts to test the safety and effectiveness of ZN-A-1041 both on its own and in combination with other cancer treatments. The study will include patients with or without brain metastases and aims to find the best dose that can be given safely.
Description
The study is divided into three phases:
Phase 1a (Monotherapy Dose Escalation): In this phase, participants will receive ZN-A-1041 by itself. The trial will start with a low dose, which will be gradually increased in new groups of participants to find the highest safe dose. This will help determine the best dose for future studies.
Phase 1b (Combination Dose Escalation): In this phase, the study will test the safety of ZN-A-1041 when given with other standard treatments for HER2-positive breast cancer. Participants will be divided into groups to receive ZN-A-1041 with either T-DM1, T-DXd, or a combination of pertuzumab and trastuzumab. This phase will help identify the best dose for these combination treatments.
Phase 1c (Combination Dose Expansion): In this final phase, more participants will receive ZN-A-1041 at the recommended doses found in Phase 1b. This will allow researchers to better understand the safety and effectiveness of these treatment combinations.
Throughout the study, participants will go through screening, treatment, and follow-up periods to gather detailed information on the safety, tolerability, and effectiveness of ZN-A-1041, both alone and in combination with other treatments.
Eligibility Criteria
Inclusion Criteria
- Must have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Expected to live at least 6 months, as determined by the study doctor.
- Have a confirmed diagnosis of HER2-positive advanced solid tumors that cannot be surgically removed or have spread to other parts of the body.
- Must have previously received treatment for metastatic disease that included a taxane and trastuzumab, or have received first-line therapy for advanced disease with a regimen based on pertuzumab and trastuzumab or T-DXd.
- Participants with new, untreated, worsening, or stable brain metastases can join the study.
Exclusion Criteria
- Participation in another clinical study with an experimental drug or device within 4 weeks before starting this study.
- Have a brain metastasis that needs immediate treatment, such as surgery or radiation, or requires corticosteroids at the time of joining the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa | 85712 | Tucson | Arizona |
| TOI Clinical Research | 90703-2684 | Cerritos | California |
| UCSF Helen Diller Family CCC | 94158 | San Francisco | California |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| University of Michigan Hospital | 48109 | Ann Arbor | Michigan |
| Barbara Ann Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| Duke University School of Medicine | 27710 | Durham | North Carolina |
| MD Anderson Cancer Center | 77030-4000 | Houston | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.