A Study of GQ1010 in Subjects With Advanced Solid Tumors
brief summary
This is an open-label, phase I/II study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of GQ1010 and preliminary anti-tumor efficacy in advanced malignant solid tumor subjects
detailed description
This is a Phase 1/2, first in human (FIH), open-label, multicenter study of GQ1010, a Trop-2 directed antibody-drug conjugate (ADC), in participants with previously treated, advanced solid tumors. The study comprises 3 parts: a Phase 1a Dose Escalation, a Phase 1b Dose Expansion, and Phase 2 study. The Phase 1a will investigate the safety and tolerability of GQ1010 and identify one or more recommended doses for expansion (RDEs) and the maximum-tolerated dose (MTD) (if exists). Once the RDEs has been established, Phase 1b will open to identify the recommended phase 2 dose (RP2D) of GQ1010. Then the phase 2 study will open to investigate the preliminary efficacy of GQ1010 in 5 cohorts with different tumor types.
official title
A Phase I/II, Multicenter, Open-Label, Dose-Escalation and Extension Study of GQ1010(an Anti-Trop2 ADC) in Subjects With Advanced Solid Tumors