Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical Carcinoma
NCT ID: NCT06241235
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2024-03-27
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation
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
ZG005 Powder for Injection
ZG005 for dose escalations are set as 10 mg/kg, 15 mg/kg and other doses after discussion, intravenous infusion(IV), once every 3 weeks (Q3W). ZG005 for dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.
Paclitaxel
IV infusion
Bevacizumab
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Part 2: Dose Expansion
Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen
ZG005 Powder for Injection
ZG005 for dose escalations are set as 10 mg/kg, 15 mg/kg and other doses after discussion, intravenous infusion(IV), once every 3 weeks (Q3W). ZG005 for dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.
Paclitaxel
IV infusion
Bevacizumab
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Interventions
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ZG005 Powder for Injection
ZG005 for dose escalations are set as 10 mg/kg, 15 mg/kg and other doses after discussion, intravenous infusion(IV), once every 3 weeks (Q3W). ZG005 for dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.
Paclitaxel
IV infusion
Bevacizumab
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female 18-70 years of age;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
* Life expectancy ≥ 3 months.
Exclusion Criteria
18 Years
70 Years
FEMALE
No
Sponsors
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jason Wu
Role: STUDY_CHAIR
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Locations
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Zhejiang Cancer Hospital
Zhejiang, Hangzhou, China
Countries
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Central Contacts
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Facility Contacts
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Hanmei Lou
Role: primary
Other Identifiers
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ZG005-003
Identifier Type: -
Identifier Source: org_study_id
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