Study #2022-0674
A Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ZN-A-1041 enteric capsules as a single agent or in combination in patients with HER2-Positive Advanced Solid Tumors
MD Anderson Study Status
Enrolling
Treatment Agent
ZN-A-1041 50mg BID, ZN-A-1041 100mg BID, ZN-A-1041 200mg BID, ZN-A-1041 400mg BID, ZN-A-1041 600mg BID, ZN-A-1041 800mg BID, ZN-A-1041 1000mg BID, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase1b, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase1b, ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase1b, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase1c, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase1c, ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase1c
Description
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 patients 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).
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Advanced Solid Tumors, HER2-positive Breast Cancer
Study phase:
Phase I
Physician name:
Rashmi Murthy
Department:
Breast Medical Oncology
For general questions about clinical trials:
1-877-211-1427
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