NTQ-1062

This is an open-label, single-arm phase 1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of NTQ1062 in combination with Fulvestrant in patients with locally advanced or metastatic HR positive/HER-2 negative breast cancer.

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).