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

ClinicalTrials.gov ID: NCT05593094

Public ClinicalTrials.gov record NCT05593094. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:07 AM EDT

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT05593094
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 210 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 3, 2020 (Actual)
Primary completion: Aug 31, 2027 (Estimated)
Completion: Aug 31, 2027 (Estimated)
Last update posted: Aug 21, 2026

2020 – 2027

United States locations

U.S. sites: 8
U.S. states: 6
U.S. cities: 8

Facility	City	State	ZIP	Site status
Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa	Tucson	Arizona	85712	—
TOI Clinical Research	Cerritos	California	90703-2684	—
UCSF Helen Diller Family CCC	San Francisco	California	94158	—
Dana Farber Cancer Institute	Boston	Massachusetts	02215	—
University of Michigan Hospital	Ann Arbor	Michigan	48109	—
Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	48201	—
Duke University School of Medicine	Durham	North Carolina	27710	—
MD Anderson Cancer Center	Houston	Texas	77030-4000	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05593094, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 21, 2026 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05593094 live on ClinicalTrials.gov.

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