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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Cervical Cancer

Treatments: Biological: Bevacizumab; Drug: Gecacitinib; Biological: ZG005

Study type: Interventional

Funder types: Industry

Identifiers

NCT07080216

ZG005-JAK-003

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

PART 1（phaseⅠ）

Experimental group

Description:

Part 1 is a dose exploratory study of ZG005 combined with gecaxitinib ± bevacizumab to evaluate the tolerability and safety of the combination regimen

Treatment:

Biological: ZG005

Drug: Gecacitinib

Biological: Bevacizumab

PART 2（phase II）

Experimental group

Description:

Part 2 is a dose expansion study to further evaluate the safety and preliminary efficacy of the combination regimen identified in Part 1

Treatment:

Biological: ZG005

Drug: Gecacitinib

Biological: Bevacizumab