Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical Carcinoma
Phase 1
Recruiting
- Conditions
- Cervical Carcinoma
- Interventions
- Drug: ZG005 Powder for InjectionBiological: Bevacizumab
- Registration Number
- NCT06241235
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Brief Summary
This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 48
Inclusion Criteria
- Fully understand the study and voluntarily sign the informed consent form.
- Female 18-70 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- Life expectancy ≥ 3 months.
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: Dose Escalation ZG005 Powder for Injection Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen Part 2: Dose Expansion Cisplatin Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen Part 1: Dose Escalation Bevacizumab Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen Part 1: Dose Escalation Cisplatin Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen Part 1: Dose Escalation Carboplatin Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen Part 2: Dose Expansion ZG005 Powder for Injection Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen Part 2: Dose Expansion Bevacizumab Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen Part 2: Dose Expansion Carboplatin Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen Part 1: Dose Escalation Paclitaxel Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen Part 2: Dose Expansion Paclitaxel Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicity (DLT) Up to 2 years Objective Response Rate (ORR) Up to 2 years ORR was defined as the percentage of the participants in the analysis population who have a Complete Response or a Partial Response. The ORR per RECIST 1.1 as assessed by Investigator is presented.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Zhejiang, Hangzhou, China