Study of ZG005 in Combination With Paclitaxel＋Platinum-based ± Bevacizumab in Patients With Advanced Cervical Carcinoma

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study ID
NCT06241235
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ZG005 Powder for Injection — DRUG
    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 — DRUG
    IV infusion
  • Bevacizumab — BIOLOGICAL
    IV infusion
  • Cisplatin — DRUG
    IV infusion
  • Carboplatin — DRUG
    IV infusion

Study Details

This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.

Key Dates

First listed
Feb 5, 2024
Start date
Mar 27, 2024
Status verified
Mar 2024
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

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

Arms

  • Experimental: 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
  • Experimental: Part 2: Dose Expansion
    Part 2 is a dose expansion study to further evaluate the initial efficacy and safety of the combination regimen

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: Up to 2 years ]

Central Contacts

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