RecruitingPhase 1Phase 2NCT07080216

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

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

120 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two investigational treatments — ZG005 and gecacitinib — in women with advanced cervical cancer. The goal is to evaluate how safe and effective this combination is for patients whose cancer has spread or come back after prior treatment. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have confirmed advanced cervical cancer (squamous cell, adenocarcinoma, or mixed type) - You are in good general health (ECOG 0–1) - You have signed informed consent to participate **You may NOT be eligible if...** - Your doctor determines you are not a suitable candidate for any reason Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALZG005

ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W)

DRUGGecacitinib

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.

BIOLOGICALBevacizumab

Bevacizumab 7.5 mg/kg，intravenous infusion(IV), once every 3 weeks (Q3W)

Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT07080216

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