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
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Advanced Solid Tumors, HER2-positive Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT05593094
- Run by
- Hoffmann-La Roche
- People needed
- 210
- Starts
- 2020-09-03
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2026-05-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa — Tucson, Arizona, United States
- TOI Clinical Research — Cerritos, California, United States
- UCSF Helen Diller Family CCC — San Francisco, California, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- University of Michigan Hospital — Ann Arbor, Michigan, United States
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
- Duke University School of Medicine — Durham, North Carolina, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Geelong Hospital — Geelong, Victoria, Australia
- Sunshine Hospital — St Albans, Victoria, Australia
- EDOG - Institut Claudius Regaud - PPDS — Toulouse, Haute-Garonne, France
- Centre Georges Francois Leclerc — Dijon, France
- Centre Oscar Lambret — Lille, France
- Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes — Lyon, France
- Institut Paoli-Calmettes — Marseille, France
- Institut de Cancerologie de l Ouest — Saint-Herblain, France
- Gustave Roussy — Villejuif, France
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS — Parma, Emilia-Romagna, Italy
- Asst Papa Giovanni XXIII — Bergamo, Lombardy, Italy
- Fondazione Policlinico Universitario A Gemelli-Rome — Magnago, Lombardy, Italy
- Auckland City Hospital — Auckland, New Zealand
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Argentona, Barcelona, Spain
- Hospital Clinico Universitario de Santiago — Santiago de Compostela, LA Coruna, Spain
- Hospital Universitario Ramon y Cajal — A Gudiña, Orense, Spain
- Hospital Universitario Virgen del Rocio — Las Cabezas de San Juan, Sevilla, Spain
Full record on ClinicalTrials.gov
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