ZG005 plus gecacitinib (with or without bevacizumab) for advanced cervical cancer
A Multicenter, Open-label, Dose-finding and Dose-expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer
This trial will test whether adding the experimental antibody ZG005 to the JAK inhibitor gecacitinib, with or without bevacizumab, is safe and shows signs of benefit in adults with advanced cervical cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | bevacizumab, Gecacitinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07080216 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label Phase 1/2 trial gives adults with advanced cervical cancer an experimental antibody, ZG005, combined with the JAK inhibitor gecacitinib, and some participants may also receive bevacizumab. The Phase 1 portion focuses on safety and tolerability to identify appropriate dosing, and the Phase 2 expansion looks for preliminary signs of anti-tumor activity. Key outcomes include adverse events, dose-limiting toxicities, and measures of tumor response and progression. Eligible participants must have histologically or cytologically confirmed advanced cervical cancer and an ECOG performance status of 0 or 1.
Who should consider this trial
Good fit: Adult women aged 18–75 with histologically confirmed advanced cervical cancer and ECOG 0–1 who can give informed consent are the intended candidates.
Not a fit: Patients with poor performance status, other active serious illnesses, or those judged unsuitable by the investigator are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this combination could provide a new treatment option that improves disease control for some patients with advanced cervical cancer.
How similar studies have performed: Related combinations of targeted antibodies, JAK inhibitors, and anti-VEGF therapy have been explored in other solid tumors with mixed but sometimes promising early-stage results, while this exact combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form. * Female 18-75 years of age; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Histologically or cytologically confirmed advanced cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Exclusion Criteria: * Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yongsheng Chu
- Email: chuys@zelgen.com
- Phone: +86-0512-57309965
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.