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

Cervical Carcinoma

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ZG005 in combination with standard chemotherapy (paclitaxel and platinum-based drugs), with or without bevacizumab, for women with advanced cervical cancer. ZG005 is an investigational agent being evaluated for safety and effectiveness when added to existing treatment. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been diagnosed with advanced cervical carcinoma - Your general health is good (ECOG performance status 0 or 1) - Your life expectancy is at least 3 months - You have read, understood, and signed the informed consent form **You may NOT be eligible if...** - Your doctor determines there are medical or other reasons that make participation unsafe or inappropriate for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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