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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
Sponsor: Hoffmann-La Roche
Summary
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2020-09-03
Completion Date
2027-07-31
Last Updated
2026-02-25
Healthy Volunteers
No
Interventions
ZN-A-1041
ZN-A-1041: escalating doses orally BID at pre-defined dosing regimens to determine the MTD
ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b
ZN-A-1041: BID via oral administration T-DM1: 3.6 mg/kg given as an intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
ZN-A-1041: BID via oral administration T-DXd: 5.4 mg/kg given as an intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b
ZN-A-1041: BID via oral administration PHESGO dose is 600 mg pertuzumab/600 mg trastuzumab/2000 unites hyaluronidase every 3 weeks for subcutaneous administrations (21-day cycle) Perjeta is 420 mg administered as an intravenous infusion Herceptin is 6 mg/kg administered as an intravenous infusion
ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c
ZN-A-1041: BID via oral administration T-DM1: intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c
ZN-A-1041: BID via oral administration T-DXd: intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)
ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c
ZN-A-1041: BID via oral administration PHESGO: every 3 weeks for subcutaneous administrations (21-day cycle) Perjeta: intravenous infusion Herceptin: intravenous infusion
Locations (36)
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
Instituto Oncologico Dr. Rosell-Hospital Universitari Dexeus-Grupo Quironsalud
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario de Jaen
Jaén, Spain
Hospital Beata Maria Ana
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
The Christie
Manchester, Lancashire, United Kingdom
Clatterbridge Cancer Centre
Liverpool, Merseyside, United Kingdom