NCT07080216

Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer

A Multicenter, Open-label, Dose-finding and Dose-expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label phase I/II study in patients with advanced cervical cancer designed to evaluate the safety, tolerability, and preliminary efficacy of ZG005 in combination with Gecacitinib ± bevacizumab.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ZG005	ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W)
DRUG	Gecacitinib	Part 1: Cohort A：Gecacitinib is administered continuously until the end of treatment; Cohort B：Gecacitinib is administered continuously from CnD1 to D14, and discontinued from CnD15 to D21；Part 2：Gecacitinib for dose exploratory stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose escalation stage.
BIOLOGICAL	Bevacizumab	Bevacizumab 7.5 mg/kg，intravenous infusion(IV), once every 3 weeks (Q3W)

Timeline

• Start date: 2025-09-23
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2025-07-23
• Last updated: 2026-01-05

Locations

1 site across 1 country: China