NCT06241235

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Cervical Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-27
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-02-05
• Last updated: 2024-04-02

Locations

1 site across 1 country: China