Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer
Not Applicable
Not yet recruiting
- Conditions
- Cervical Cancer
- Interventions
- Registration Number
- NCT07080216
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
- 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 Criteria
- Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PART 1（phaseⅠ） ZG005 Part 1 is a dose exploratory study of ZG005 combined with gecaxitinib ± bevacizumab to evaluate the tolerability and safety of the combination regimen PART 1（phaseⅠ） Gecacitinib Part 1 is a dose exploratory study of ZG005 combined with gecaxitinib ± bevacizumab to evaluate the tolerability and safety of the combination regimen PART 1（phaseⅠ） Bevacizumab Part 1 is a dose exploratory study of ZG005 combined with gecaxitinib ± bevacizumab to evaluate the tolerability and safety of the combination regimen PART 2（phase II） ZG005 Part 2 is a dose expansion study to further evaluate the safety and preliminary efficacy of the combination regimen identified in Part 1 PART 2（phase II） Gecacitinib Part 2 is a dose expansion study to further evaluate the safety and preliminary efficacy of the combination regimen identified in Part 1 PART 2（phase II） Bevacizumab Part 2 is a dose expansion study to further evaluate the safety and preliminary efficacy of the combination regimen identified in Part 1
- Primary Outcome Measures
Name Time Method Adverse Event (AE) Up to 2 years Objective response rate (ORR) Up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital🇨🇳Hangzhou, Zhejiang, ChinaHanmei LouContact