drugset / Trial / NCT04622072

XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT04622072 ↗

Phase 1 Terminated 21 enrolled Sihuan Pharmaceutical Holdings Group Ltd.
NaSequentialOpen-labelTreatment

Summary

The trial is divided into two parts, one is dose escalation phase, the second one is dose expansion phase. For dose escalation phase, the main purpose is to evaluate safety and tolerability of XZP-5809-TT1 tablets after treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer, and to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). For dose expansion phase, the main purpose is to evaluate Objective response rate (ORR) in patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Timeline

Start
2020-11-02
Primary completion
2021-05-20
Completion
2022-04-27

Outcome

Outcome not reported

Stopped (Business): “Strategic considerations”

Drugs

EvaluationDrugModalityDoseRoute
Subject XZP-5809 Unknown — —