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NCT Number: NCT07080216

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location status: Recruiting

Location contact

Hanmei Lou

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZG005

Biological

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

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

Primary outcomes

  1. Adverse Event (AE)

    Time frame: Up to 2 years

  2. Objective response rate (ORR)

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Yongsheng Chu

CONTACT

[email protected]

+86-0512-57309965

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Multicenter, Open-label, Dose-finding and Dose-expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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