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
Key facts
- Who runs it
- Hoffmann-La Roche
- Where
- Ann Arbor, Boston, Cerritos, Detroit, Durham, Houston, San Francisco, and Tucson, United StatesSee the 8 sitesAlso in 6 other countries, 28 sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 1/2
- People taking part
- 210 people, planned
- Started
- 3 Sept 2020
- Expected to end
- 31 Aug 2027
- Type of study
- Interventional, 7 groups
- Treatments 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
- ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b
- ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c
- ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c
- ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c
- Record updated
- 21 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
Where in United States
Also in 6 other countries, 28 sites
- University of Michigan HospitalAnn Arbor, United States
- Dana-Farber Cancer InstituteBoston, United States
- TOI Clinical ResearchCerritos, United States
- Barbara Ann Karmanos Cancer InstituteDetroit, United States
- Duke University School of MedicineDurham, United States
- MD Anderson Cancer CenterHouston, United States
- UCSF Helen Diller Family CCCSan Francisco, United States
- Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - AoaTucson, United States
About the trial
What the trial wants to find out
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.
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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).
The 7 groups in the trial
- 1a: ZN-A-1041Treatment being tested
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).
Treatment: ZN-A-1041
- 1b: ZN-A-1041 + T-DM1 3.6 mg/kg iv.Treatment being tested
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.
Treatment: ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b
- 1b: ZN-A-1041 + T-Dxd 5.4 mg/kg iv.Treatment being tested
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.
Treatment: ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
- 1b: ZN-A-1041 + PHESGO / Herceptin plus PerjetaTreatment being tested
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.
Treatment: ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b
- 1c: ZN-A-1041 + T-DM1 3.6 mg/kg iv.Treatment being tested
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.
Treatment: ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c
- 1c: ZN-A-1041 + T-Dxd 5.4 mg/kg iv.Treatment being tested
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.
Treatment: ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c
- 1c: ZN-A-1041 + Herceptin plus Perjeta/PHESGOTreatment being tested
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.
Treatment: ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Record updated
- 21 August 2026