Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer

May 11, 2025 updated by: Lee's Pharmaceutical Limited

Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study

The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is:

Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab.

Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6~8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Able to understand and voluntarily signed written informed consent. Informed consent must be signed prior to specified study procedure.
  • 2. Age ≥ 18 years and ≤75 years on the date of signing the informed consent, female.
  • 3. ECOG Physical fitness score was 0 or 1.
  • 4. Life expectancy ≥ 3 months.
  • 5. Histologically confirmed cervical cancer that cannot be cured by surgery or radiotherapy/concurrent chemoradiotherapy.
  • 6. Have at least one measurable tumor lesion examined by CT or MRI according to RECIST v1.1 criteria;
  • 7. All subjects must provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded [FFPE] tissue wax blocks or at least 5 unstained tumor tissue section samples, preferably newly obtained tumor tissue samples) within the previous 5 years of randomization.
  • 8. Laboratory examination results during the screening period indicate that the subject has good organ function.
  • 9. Effective contraception should be used by fertile female subjects from the signing of informed consent until 180 days after the last administration of the study drug.

Exclusion Criteria:

  • 1. Other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.
  • 2. Prior anti-angiogenic therapy (e.g., bevacizumab), immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), or targeting immune costimulators (e.g. antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.) and any treatment targeting the immune mechanism of tumor.
  • 3. Active or potentially recurring autoimmune disease.
  • 4. Patients with other active malignant tumors within 3 years prior to randomization.
  • 5. Participants who had participated in other clinical studies and used other clinical trial drugs within 4 weeks before randomization.
  • 6. Major surgery, open biopsy or significant trauma within 4 weeks before randomization; Or an expected major surgical treatment during the study.
  • 7. Anti-tumor therapy within 4 weeks before randomization.
  • 8. Severe infection occurring within 4 weeks prior to randomization.
  • 9. Vaccination within 4 weeks prior to randomization.
  • 10. Received immune-modulating drugs (such as thymosin, interferon, interleukin-2) within 2 weeks before randomization.
  • 11. Use of systemic antibacterial, antiviral, or antifungal drugs within 2 weeks prior to randomization.
  • 12. Subjects requiring systemic treatment with corticosteroids (> 10 mg/ day of prednisone or equivalent doses of corticosteroids) or other immunosuppressive drugs within 2 weeks prior to randomization.
  • 13. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as determined by the investigator.
  • 14. Central nervous system metastatic or cancerous meningitis.
  • 15. Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated drainage (more frequently than monthly).
  • 16. Known primary or secondary immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies.
  • 17. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • 18. Known active tuberculosis; Known active treponema pallidum infection.
  • 19. known history of severe hypersensitivity to other monoclonal antibodies.
  • 20. Known contraindications to cisplatin/carboplatin, paclitaxel, or allergies to any components.
  • 21. Previous and/or current presence of interstitial lung disease, pneumoconiosis, drug-related pneumonia, severe impairment of pulmonary function, etc., that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
  • 22. Subjects with active viral hepatitis B, inactive or asymptomatic carriers of hepatitis B virus (HBV) (positive for hepatitis B surface antigen [HBsAg]) with HBV DNA > 500 IU/mL or > 2500 copies/mL), and subjects with active viral hepatitis C.
  • 23. Active or documented inflammatory bowel disease.
  • 24. Any of the following cardiovascular diseases: a) myocardial infarction, unstable angina pectoris, pulmonary embolism, aortic dissection, deep vein thrombosis, and any arterial thromboembolism event occurred within 6 months before randomization; b) New York Heart Association (NYHA) heart function grade ≥ II heart failure; c) There is a serious arrhythmia that requires drug intervention; Patients with asymptomatic atrial fibrillation with stable ventricular rate were admitted; d)Left ventricular ejection fraction (LVEF) < 50%.
  • 25. NCI CTCAE v5.0 ≥ 2 grade peripheral neuropathy.
  • 26. Not recovered from toxicity of previous antitumor therapy.
  • 27. Pregnant or lactating women.
  • 28. Any condition (such as another serious illness or psychiatric disorder) that the investigator believes may result in a risk for acceptance of the study drug or that would interfere with the evaluation of the study drug or with the safety of the subjects or the interpretation of the study results.
  • 29. Known contraindications to bevacizumab or allergies to any of its components, or the presence of any medical conditions that could affect the safety of bevacizumab administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Socazolimab+Chemotherapy±Bevacizumab

6~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w.

Followed with Socazolimab (5 mg/kg), Q3w.
Drug: Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab

6~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w.

Followed with Socazolimab (5 mg/kg), Q3w.
Placebo Comparator: Placebo+Chemotherapy±Bevacizumab

6~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w.

Followed with placebo (5 mg/kg), Q3w.
Drug: Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab

6~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w.

Followed with placebo (5 mg/kg), Q3w.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: From date of randomization to date of death from any cause, assessed up to 100 months.
From date of randomization to date of death from any cause, assessed up to 100 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS (assessed by BICR, based on RECIST v1.1)
Time Frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
ORR (assessed by BICR, based on RECIST v1.1)
Time Frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DoR (assessed by BICR, based on RECIST v1.1)
Time Frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DCR (assessed by BICR, based on RECIST v1.1)
Time Frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
TTR (assessed by BICR, based on RECIST v1.1)
Time Frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
PFS (assessed by investigators, based on RECIST v1.1)
Time Frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
ORR (assessed by investigators, based on RECIST v1.1)
Time Frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DoR (assessed by investigators, based on RECIST v1.1)
Time Frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DCR (assessed by investigators, based on RECIST v1.1)
Time Frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
TTR (assessed by investigators, based on RECIST v1.1)
Time Frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
Safety: adverse events, clinical abnormalties
Time Frame: from written informed concent to 90 days after last dose
from written informed concent to 90 days after last dose
Tmax
Time Frame: from 30min before first dose to 30 days after last dose
from 30min before first dose to 30 days after last dose
Cmax
Time Frame: from 30min before first dose to 30 days after last dose
from 30min before first dose to 30 days after last dose
T1/2
Time Frame: from 30min before first dose to 30 days after last dose
from 30min before first dose to 30 days after last dose
Immunogenicity
Time Frame: from 30min before first dose to 30 days after last dose
ADA, NAb
from 30min before first dose to 30 days after last dose
Health-related quality of life (HRQoL)
Time Frame: from screening to end of treatment visit, up to 100 months
using EORTC QLQ-C30 Questionnaire
from screening to end of treatment visit, up to 100 months
PD-L1 status
Time Frame: up to 100 months
up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lee's Pharmaceutical Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 11, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZKAB001-LEES-2024-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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