NCT06172309

A Phase I Study of NTQ1062 in Chinese Patients With Advanced Solid Tumors

A Phase I Study of Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamic Effect of NTQ1062 Tablets in Chinese Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effect of NTQ1062 in patients with advanced solid tumors. The study comprises a dose-escalation phase and a dose-expansion phase. 1. Dose-escalation:using 3+3 design to evaluate the safety, tolerability, and pharmacokinetic profile of NTQ1062 at 20, 50, 100, 200, 300, 400 mg in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD). 2. Dose-expansion:the dose-expansion study will evaluate the safety, tolerability, and preliminary pharmacodynamic effect of the MTD for NTQ1062 in patients with advanced solid tumors, and to identify the recommended phase 2 dose (RP2D).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	NTQ1062	tablet(s) PO

Timeline

• Start date: 2021-09-24
• Primary completion: 2024-04-20
• Completion: 2024-05-27
• First posted: 2023-12-15
• Last updated: 2024-07-29

Locations

2 sites across 1 country: China