A Phase I Study of NTQ1062 in Chinese Patients With Advanced Solid Tumors
Status:
Active, not recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
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).