A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors

Cancer
Solid Tumors
Advanced Solid Tumors
Breast Cancer
HER2-Positive Breast Cancer

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 1/Phase 2

Trial Identifier NCT05593094, XO45189, ZN-A-1041-101-US,2023-508459-37-00

Condition Advanced Solid Tumors, HER2-positive Breast Cancer

Official Title A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors

Study Summary

This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in participants with HER2-positive advanced solid tumors with or without brain metastases. The study will consist of three phases: Phase 1a (dose escalation with ZN-A-1041 monotherapy), Phase 1b (dose escalation with ZN-A-1041 combination therapy) and Phase 1c (dose expansion with ZN-A-1041 combination therapy).

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 6 months, as determined by the investigator
Histologically or cytologically confirmed with unresectable or metastatic HER2-positive advanced solid tumors
Must be relapsed or refractory after prior treatment for metastatic disease that included a taxane and trastuzumab or must have received first-line induction therapy for advanced disease a pertuzumab plus trastuzumab-based regimen or a T-DXd-based regimen
Participants with new, untreated, progressive, or stable brain metastases are eligible

Exclusion Criteria

Participation in any other clinical study involving an investigational drug or device within 4 weeks prior to the first dose of study treatment
Any intracranial lesion (brain metastasis) that requires immediate local therapy, such as surgery or radiation, or systemic corticosteroids at the time of enrollment

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

For the latest version of this information please go to www.forpatients.roche.com

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A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors

For the latest version of this information please go to www.forpatients.roche.com