drugset
drugset / Trial / NCT04487236

Trial of ZN-A-1041 Enteric Capsules in Patients With HER2-Positive Advanced Solid Tumors

NCT04487236 ↗

Phase 1 Completed 61 enrolled Suzhou Zanrong Pharma Limited
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 patients with HER2-positive advanced solid tumors. The study will consist of three phases: phase 1a (dose escalation with ZN-A-1041 monotherapy), phase 1b (dose escalation with ZN-A-1041 in combination with Capecitabine and Trastuzumab) and phase 1c (dose expansion with ZN-A-1041 in combination with Capecitabine and Trastuzumab).

Timeline

Start
2020-10-15
Primary completion
2024-04-16
Completion
2025-04-16

Drugs

EvaluationDrugModalityDoseRoute
Subject ZN-A-1041 Unknown 50 mg Oral
Subject ZN-A-1041 Unknown 100 mg Oral
Subject ZN-A-1041 Unknown 200 mg Oral
Subject ZN-A-1041 Unknown 400 mg Oral
Subject ZN-A-1041 Unknown 600 mg Oral
Subject ZN-A-1041 Unknown 800 mg Oral
Subject ZN-A-1041 Unknown 1000 mg Oral
Background Capecitabine Small molecule 1000 mg/m2 —
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications

HER2 positive breast carcinoma