1/2상모집 중단 (진행 중)
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
연구 개요
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).
- 스폰서
- 리드: 로슈
- 적응증
- Advanced Solid Tumors, HER2-positive Breast Cancer
- 중재
- 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, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c, ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c
- 목표 등록
- 210명
- 시작일
- 2020-09-03
- 완료(예정)
- 2027-08-31
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