NCT04408079

A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets

A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. Phase Ia: dose escalation period, to evaluate the safety and tolerability of TQB3558 tablets, determine MTD; Phase Ib: effectiveness exploration period, to expand the safe and effective dose group, recommend appropriate dosage and method for subsequent clinical research.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	TQB3558	TQB3558 is a kinase inhibitor of the TRK protein family.

Timeline

• Start date: 2020-06-25
• Primary completion: 2022-07-31
• Completion: 2022-10-31
• First posted: 2020-05-29
• Last updated: 2020-07-08

Locations

1 site across 1 country: China