Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZG005, Gecacitinib, Bevacizumab.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
This is a multicenter, open-label phase I/II study in patients with advanced cervical cancer designed to evaluate the safety, tolerability, and preliminary efficacy of ZG005 in combination with Gecacitinib ± bevacizumab.
Interventions
- Biological ZG005
ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W) - Drug Gecacitinib
Part 1: Cohort A：Gecacitinib is administered continuously until the end of treatment; Cohort B：Gecacitinib is administered continuously from CnD1 to D14, and discontinued from CnD15 to D21；Part 2：Gecacitinib for dose exploratory stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose escalation stage. - Biological Bevacizumab
Bevacizumab 7.5 mg/kg，intravenous infusion(IV), once every 3 weeks (Q3W)
Primary outcome measures
- Adverse Event (AE) [Time frame: Up to 2 years]
- Objective response rate (ORR) [Time frame: Up to 2 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT07080216 · ZG005-JAK-003