Cervical Cancer
Conditions
Brief summary
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
BIOLOGICALZG005
ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W)
DRUGGecacitinib
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.
BIOLOGICALBevacizumab
Bevacizumab 7.5 mg/kg，intravenous infusion(IV), once every 3 weeks (Q3W)
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event (AE) | Up to 2 years |
| Objective response rate (ORR) | Up to 2 years |
Countries
China
Contacts
Primary ContactYongsheng Chu
Outcome results
None listed