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RECRUITING
NCT07080216
PHASE1/PHASE2

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

Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-09-23

Completion Date

2027-12

Last Updated

2026-01-05

Healthy Volunteers

No

Conditions

Interventions

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)

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China