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NCT06241235 Clinical Trial

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
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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