210
Participants
Start Date
September 3, 2020
Primary Completion Date
October 30, 2025
Study Completion Date
October 30, 2026
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
Auckland City Hospital, Auckland
Sunshine Hospital, St Albans
Geelong Hospital, Geelong
Institut Paoli-Calmettes, Marseille
Hospital Clinico Universitario de Santiago, Santiago de Compostela
Fondazione Policlinico Universitario A Gemelli-Rome, Magnago
Centre Georges Francois Leclerc, Dijon
Hospital Universitario de Jaen, Jaén
Asst Papa Giovanni XXIII, Bergamo
Duke University School of Medicine, Durham
Hospital Beata Maria Ana, Madrid
Hospital Clinico San Carlos, Madrid
Hospital Universitario 12 de Octubre, Madrid
EDOG - Institut Claudius Regaud - PPDS, Toulouse
Hospital Universitario Ramon y Cajal, A Gudiña
Hospital Universitario Virgen Macarena, Seville
Hospital Universitario Virgen del Rocio, Las Cabezas de San Juan
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS, Parma
Institut de Cancerologie de l Ouest, Saint-Herblain
Fundacion Instituto Valenciano de Oncologia (IVO), Valencia
Hospital Clinico Universitario de Valencia, Valencia
University of Michigan Hospital, Ann Arbor
Barbara Ann Karmanos Cancer Institute, Detroit
Centre Oscar Lambret, Lille
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes, Lyon
Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa, Tucson
UCSF Helen Diller Family CCC, San Francisco
Gustave Roussy, Villejuif
TOI Clinical Research, Cerritos
Dana Farber Cancer Institute, Boston
MD Anderson Cancer Center, Houston
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON, Argentona
Instituto Oncologico Dr. Rosell-Hospital Universitari Dexeus-Grupo Quironsalud, Barcelona
Hospital Clinic de Barcelona, Barcelona
The Christie, Manchester
Clatterbridge Cancer Centre, Liverpool
Hoffmann-La Roche
INDUSTRY