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

NCT07080216 | Recruiting Phase 1

• 1 other identifier: ZG005-JAK-003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Adverse Event (AE)

  Up to 2 years

• Objective response rate (ORR)

  Up to 2 years

Study Arms (2)

PART 1（phaseⅠ）

EXPERIMENTAL

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

Biological: ZG005; Drug: Gecacitinib; Biological: Bevacizumab

PART 2（phase II）

EXPERIMENTAL

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

Biological: ZG005; Drug: Gecacitinib; Biological: Bevacizumab

Interventions

ZG005 BIOLOGICAL

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

PART 1（phaseⅠ）; PART 2（phase II）

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.

PART 1（phaseⅠ）; PART 2（phase II）

Bevacizumab BIOLOGICAL

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

PART 1（phaseⅠ）; PART 2（phase II）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Yongsheng Chu

CONTACT

+86-0512-57309965; chuys@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-07

Locations

CN (1)