Cervical Carcinoma
Conditions
Brief summary
This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.
Interventions
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.
DRUGPaclitaxel
IV infusion
BIOLOGICALBevacizumab
IV infusion
DRUGCisplatin
IV infusion
DRUGCarboplatin
IV infusion
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 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity (DLT) | Up to 2 years | — |
| Objective Response Rate (ORR) | Up to 2 years | 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. |
Countries
China
Contacts
Primary ContactYongsheng Chu
Outcome results
None listed