Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study ID
NCT07080216
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ZG005 — BIOLOGICAL
    ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W)
  • Gecacitinib — DRUG
    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 — BIOLOGICAL
    Bevacizumab 7.5 mg/kg，intravenous infusion(IV), once every 3 weeks (Q3W)

Study Details

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.

Key Dates

First listed
Jul 23, 2025
Start date
Sep 23, 2025
Status verified
Jul 2025
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Adverse Event (AE) [ Time Frame: Up to 2 years ]

Central Contacts

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