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

Summary

Participation Requirements

Description

Phase 1a of the study will adopt the "modified 3+3" dose escalation design with a total of 7 planned dose levels. Patients with HER2-positive advanced solid tumor (including those with brain metastases) will be enrolled to receive a single-dose administration of ZN-A-1041 followed by multiple-dose a...

Phase 1a of the study will adopt the "modified 3+3" dose escalation design with a total of 7 planned dose levels. Patients with HER2-positive advanced solid tumor (including those with brain metastases) will be enrolled to receive a single-dose administration of ZN-A-1041 followed by multiple-dose administration of ZN-A-1041.Phase 1b of the study will adopt the "traditional 3+3" dose escalation design with a total of 2 planned dose levels. The dose levels will be determined based on the MTD identified in the phase 1a study. In phase 1b, patients with HER2-positive advanced breast cancer (including those with brain metastases) will be enrolled to receive multiple doses of ZN-A-1041 in combination with Capecitabine. Patients with HER2-positive breast cancer with brain metastases were planned to be enrolled in the Phase 1c of the study to receive ZN-A-1041 in combination with Capecitabine. The dose levels will be determined based on the recommended doses obtained from the Phase 1b study. Each phase of the study includes a screening period, a treatment period and a follow-up period. During the trial, the safety, tolerability, PK and efficacy data of ZN-A-1041 as monotherapy and in combination with Capecitabine in the subjects will be collected and analyzed, thereby providing RP2D for the subsequent clinical trials.

Tracking Information