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 (NCT05593094)
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
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
- ZN-A-1041 (DRUG)
- ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b (DRUG)
- ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b (DRUG)
- ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b (DRUG)
- ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c (DRUG)
- ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c (DRUG)
- ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c (DRUG)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (36 Sites)
Showing the first 25 of 36 sites.
- Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa — Tucson, Arizona
- TOI Clinical Research — Cerritos, California
- UCSF Helen Diller Family CCC — San Francisco, California
- Dana Farber Cancer Institute — Boston, Massachusetts
- University of Michigan Hospital — Ann Arbor, Michigan
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan
- Duke University School of Medicine — Durham, North Carolina
- MD Anderson Cancer Center — Houston, Texas
- Geelong Hospital — Geelong, Victoria
- Sunshine Hospital — St Albans, Victoria
- EDOG - Institut Claudius Regaud - PPDS — Toulouse, Haute-Garonne
- Centre Georges Francois Leclerc — Dijon,
- Centre Oscar Lambret — Lille,
- Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes — Lyon,
- Institut Paoli-Calmettes — Marseille,
- Institut de Cancerologie de l Ouest — Saint-Herblain,
- Gustave Roussy — Villejuif,
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS — Parma, Emilia-Romagna
- Asst Papa Giovanni XXIII — Bergamo, Lombardy
- Fondazione Policlinico Universitario A Gemelli-Rome — Magnago, Lombardy
- Auckland City Hospital — Auckland,
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Argentona, Barcelona
- Hospital Clinico Universitario de Santiago — Santiago de Compostela, LA Coruna
- Hospital Universitario Ramon y Cajal — A Gudiña, Orense
- Hospital Universitario Virgen del Rocio — Las Cabezas de San Juan, Sevilla
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.