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

Cervical Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241235
• Other study ID #: ZG005-003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 27, 2024
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Yongsheng Chu
• Phone: +8651257309965
• Email: chuys[@]zelgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

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

Related Conditions & MeSH terms

• Carcinoma
• Cervical Carcinoma

Intervention

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.
• Paclitaxel
IV infusion

Biological:
• Bevacizumab
IV infusion

Drug:
• Cisplatin
IV infusion
• Carboplatin
IV infusion

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Zhejiang	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity (DLT)		Up to 2 years
Primary	Objective Response Rate (ORR)	ORR was defined as the percentage of the participants in the analysis population who have a Complete Response or a Partial Response. The ORR per RECIST 1.1 as assessed by Investigator is presented.	Up to 2 years