NCT04622072

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

A Single-arm, Open, Multi-center Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Effectiveness of XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Have Progressed After Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI).

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	XZP-5809-TT1 Tablet	Single tartrate of XZP-5809

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-05-20
• Completion: 2022-04-27
• First posted: 2020-11-09
• Last updated: 2023-02-17

Locations

5 sites across 1 country: China