RecruitingPhase 1Phase 2NCT06241235

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

A Phase I/II Study to Evaluate Safety and Pharmacokinetics and Initial Efficacy of ZG005 in Combination With Paclitaxel Plus Cisplatin/Carboplatin ± Bevacizumab in Patients With Advanced Cervical Carcinoma


Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

48 participants

Start Date

Mar 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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 Criteria1

  • Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Interventions

DRUGZG005 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.

DRUGPaclitaxel

IV infusion

BIOLOGICALBevacizumab

IV infusion

DRUGCisplatin

IV infusion

DRUGCarboplatin

IV infusion


Locations(1)

Zhejiang Cancer Hospital

Zhejiang, Hangzhou, China

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NCT06241235


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