drugset / Trial / NCT05593094
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
Non-randomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2020-09-03
- Primary completion
- 2027-08-31
- Completion
- 2027-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ZN-A-1041 | Unknown | — | Oral |
| Background | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Background | Phesgo | Unknown | — | Subcutaneous |
| Background | T-DXd | Unknown | 5.4 mg/kg | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | Intravenous |