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Sponsor: Hoffmann-La Roche
Conditions: Advanced Solid Tumors, HER2-positive Breast Cancer
Interventions: 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
Countries: United States, Australia, France, Italy, New Zealand, Spain, United Kingdom
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).
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * 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 Exclusion Criteria: * 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
- Tucson, Arizona, United States
- Cerritos, California, United States
- San Francisco, California, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Durham, North Carolina, United States
- Houston, Texas, United States
- Geelong, Victoria, Australia
- St Albans, Victoria, Australia
- Toulouse, Haute-Garonne, France
- Dijon, France
- Lille, France
- Lyon, France
- Marseille, France
- Saint-Herblain, France
- Villejuif, France
- Parma, Emilia-Romagna, Italy
- Bergamo, Lombardy, Italy
- Magnago, Lombardy, Italy
- Auckland, New Zealand
- Argentona, Barcelona, Spain
- Santiago de Compostela, LA Coruna, Spain
- A Gudiña, Orense, Spain
- Las Cabezas de San Juan, Sevilla, Spain
- Barcelona, Spain
- Barcelona, Spain
- Jaén, Spain
- Madrid, Spain
- Madrid, Spain
- + 6 more on CT.gov