Suspended

ZN-A-1041 Enteric Capsules for HER2-Positive Advanced Solid Tumors

Study Aim

This study evaluates the safety and effectiveness of ZN-A-1041 capsules, alone or in combination with other treatments, in people with advanced HER2-positive solid tumors to find the best dose with the fewest side effects.

What is being tested

ZN-A-1041

+ ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b

+ ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b

Drug

Who is being recruted

Brain Diseases+5

+ Brain Neoplasms

+ Central Nervous System Diseases

Over 18 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: September 2020

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: December 13, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: September 3, 2020

Actual date on which the first participant was enrolled.

This clinical trial focuses on evaluating a new treatment option, ZN-A-1041, for individuals with advanced solid tumors that have a specific feature known as HER2-positive. HER2-positive tumors are known to be aggressive and challenging to treat, so finding effective therapies is crucial. This study is important because it aims to determine the safest and most effective way to use ZN-A-1041, both on its own and in combination with other established cancer treatments. This could potentially lead to better treatment outcomes and improve quality of life for patients with these types of cancers. During the study, participants will receive ZN-A-1041 in capsule form. The trial is divided into three phases. Initially, the drug will be administered alone in gradually increasing doses to determine the maximum safe dose. Next, ZN-A-1041 will be combined with standard treatments like T-DM1, T-DXd, or combinations of other cancer drugs to find the best dosing strategy. Finally, more participants will join to further assess how well these combinations work. Throughout the study, researchers will monitor participants for any side effects and measure the drug's impact on the tumors, ensuring any adverse effects are manageable and evaluating the overall safety and effectiveness of the treatment.

Official TitleA 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

NCT05593094

Principal SponsorHoffmann-La Roche

Last updated: December 13, 2025

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

210 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain NeoplasmsCentral Nervous System DiseasesNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsCentral Nervous System Neoplasms

Criteria

5 inclusion criteria required to participate

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

Show More Criteria

2 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

7 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Phase 1a: Participants will receive escalating doses of ZN-A-1041 orally twice a day (BID) at pre-defined dosing regimens to determine the maximum tolerated dose (MTD).

Group II

Experimental

Phase 1b Arm1: 1. If the maximum tolerated dose (MTD) of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2). 2. If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study.

Group III

Experimental

Phase 1b Arm2: 1. If the MTD of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2). 2. If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study.

Group IV

Experimental

Phase 1b Arm3: 1. If the MTD of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2). 2. If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study.

Group 5

Experimental

Phase 1c Arm1: The recommended dose combination for Phase 1c will be determined by the Investigator and the Sponsor based on the data from Phase 1b.

Group 6

Experimental

Phase 1c Arm2: The recommended dose combination for Phase 1c will be determined by the Investigator and the Sponsor based on the data from Phase 1b.

Group 7

Experimental

Phase 1c Arm3: The recommended dose combination for Phase 1c will be determined by the Investigator and the Sponsor based on the data from Phase 1b.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 36 locations

Suspended

Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa

Tucson, United StatesSee the location

Suspended

TOI Clinical Research

Cerritos, United States

Suspended

UCSF Helen Diller Family CCC

San Francisco, United States

Suspended

Dana Farber Cancer Institute

Boston, United States

Suspended36 Study Centers