NCT06464055

A Study of GQ1010 in Subjects With Advanced Solid Tumors

A Phase I/II, Multicenter, Open-Label, Dose-Escalation and Extension Study of GQ1010(an Anti-Trop2 ADC) in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	Dose Escalation	Drug: GQ1010
DRUG	Dose Expansion1	Drug: GQ1010 dose 1
DRUG	Dose Expansion2	Drug: GQ1010 dose 2
DRUG	Dose Expansion3	Drug: GQ1010 dose 3
DRUG	phase II	Drug: GQ1010 RP2D

Timeline

• Start date: 2024-05-23
• Primary completion: 2028-05-23
• Completion: 2028-12-31
• First posted: 2024-06-18
• Last updated: 2025-02-10

Locations

5 sites across 1 country: China