Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer
NCT ID: NCT07080216
Last Updated: 2026-01-05
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
120 participants
INTERVENTIONAL
2025-09-23
2027-12-31
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 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
ZG005
ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W)
Gecacitinib
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
Bevacizumab 7.5 mg/kg，intravenous infusion(IV), once every 3 weeks (Q3W)
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
ZG005
ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W)
Gecacitinib
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
Bevacizumab 7.5 mg/kg，intravenous infusion(IV), once every 3 weeks (Q3W)
Interventions
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ZG005
ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W)
Gecacitinib
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
Bevacizumab 7.5 mg/kg，intravenous infusion(IV), once every 3 weeks (Q3W)
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 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
Hangzhou, Zhejiang, 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-JAK-003
Identifier Type: -
Identifier Source: org_study_id
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