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RECRUITING
NCT06241235
PHASE1/PHASE2

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

Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-03-27

Completion Date

2026-05

Last Updated

2024-04-02

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

Paclitaxel

IV infusion

BIOLOGICAL

Bevacizumab

IV infusion

DRUG

Cisplatin

IV infusion

DRUG

Carboplatin

IV infusion

Locations (1)

Zhejiang Cancer Hospital

Zhejiang, Hangzhou, China