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
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Yongsheng Chu
chuys@zelgen.com
+86-0512-57309965
Time Frame
Start Date: 2025-09-23
Estimated Completion Date: 2027-12
Participants
Target number of participants: 120
Treatments
Experimental: PART 1（phaseⅠ）
Part 1 is a dose exploratory study of ZG005 combined with gecaxitinib ± bevacizumab to evaluate the tolerability and safety of the combination regimen
Experimental: PART 2（phase II）
Part 2 is a dose expansion study to further evaluate the safety and preliminary efficacy of the combination regimen identified in Part 1
Related Therapeutic Areas
Sponsors
Leads: Suzhou Zelgen Biopharmaceuticals Co.,Ltd