Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • ZG005

    Biological/Vaccine

    ZG005 20mg/kg, intravenous infusion(IV), once every 3 weeks (Q3W)

  • Gecacitinib

    Drug

    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.

  • Bevacizumab

    Biological/Vaccine

    Bevacizumab 7.5 mg/kg,intravenous infusion(IV), once every 3 weeks (Q3W)

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: PART 1(phaseⅠ)Experimental treatment 3 interventions
Group B: PART 2(phase II)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse Event (AE)

Time frame
Up to 2 years
2

Objective response rate (ORR)

Time frame
Up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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