About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Trial design
Sequential
Treatments tested in this trial
ZG005
Biological/VaccineZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W)
Gecacitinib
DrugPart 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.
Bevacizumab
Biological/VaccineBevacizumab 7.5 mg/kg,intravenous infusion(IV), once every 3 weeks (Q3W)
Treatment groups
Trial outcomes
Primary outcomes
Adverse Event (AE)
Objective response rate (ORR)
Sponsors and contacts
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