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
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
120 participants
Sep 23, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Fully understand the study and voluntarily sign the informed consent form.
- Female 18-75 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Histologically or cytologically confirmed advanced cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
Exclusion Criteria1
- Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Interventions
ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W)
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.
Bevacizumab 7.5 mg/kg，intravenous infusion(IV), once every 3 weeks (Q3W)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07080216