Treatment for advanced cervical cancer using ZG005 with chemotherapy
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
This study is testing a new treatment called ZG005 combined with chemotherapy to see if it helps people with advanced cervical cancer feel better and improve their treatment results.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Zhejiang, Hangzhou) |
| Trial ID | NCT06241235 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label phase I/II study investigates the efficacy of ZG005 in combination with standard chemotherapy agents, including Paclitaxel and platinum-based drugs, in patients with advanced cervical carcinoma. The study aims to evaluate the safety and effectiveness of this novel treatment approach as a first-line therapy. Participants will receive ZG005 Powder for Injection alongside chemotherapy to assess potential improvements in treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18-70 with advanced cervical carcinoma and an ECOG performance status of 0.
Not a fit: Patients who are not suitable for participation as determined by the investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced cervical cancer.
How similar studies have performed: While this approach is novel, similar studies combining targeted therapies with chemotherapy have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Zhejiang, Hangzhou
- Zhejiang Cancer Hospital — Zhejiang, Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Yongsheng Chu
- Email: chuys@zelgen.com
- Phone: +8651257309965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.