A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody in Subjects With Recurrent/Metastatic Cervical Cancer

NCT ID: NCT04380805

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2023-01-31

Brief Summary

This is a Phase 2, global, multicenter, open label, single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic cervical carcinoma.

Conditions

Recurrent Cervical Cancer; Metastatic Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK104

AK104 monotherapy

Group Type: EXPERIMENTAL

AK104

Intervention Type: BIOLOGICAL

All subjects will receive AK104 as a single agent at a dose of 6 mg/kg Q2W (Day 1 and Day 15 of each 28 day treatment cycle) via IV infusion.

Interventions

AK104

All subjects will receive AK104 as a single agent at a dose of 6 mg/kg Q2W (Day 1 and Day 15 of each 28 day treatment cycle) via IV infusion.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Able to provide written and signed informed consent and any locally required authorization obtained from the subject/legal representative.

2. Women aged ≥18 years at the time of study entry.

3. Subjects must have histologically or cytologically confirmed recurrent or metastatic squamous carcinoma or adenosquamous carcinoma of the cervix, and meet the following criteria: disease progression confirmed by radiologic imaging during or following prior platinum based doublet chemotherapy, with or without bevacizumab for recurrent or metastatic cervical cancer; No more than 2 prior systemic therapies in the recurrent or metastatic setting.

4. Subjects must have measurable lesions according to RECIST v1.1. The presence of measurable lesions must be confirmed by the IRRC. A previously irradiated lesion is not considered measurable and cannot be selected as a target lesion.

5. Available archived tumor tissue sample - block or a minimum of 10 unstained slides of formalin fixed paraffin embedded [FFPE] tissues - preferably from the most recent biopsy of a tumor lesion collected either at the time of or after the diagnosis of locally advanced, recurrent, and/or metastatic disease has been made.

6. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.

7. Life expectancy ≥12 weeks.

8. Adequate organ function.

Exclusion Criteria

1. Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study.

2. Histological types of cervical cancer other than squamous carcinoma and adeno-squamous carcinoma (eg, adenocarcinoma, small cell carcinoma, clear cell carcinoma, sarcoma, etc).

3. Prior malignancy active within the previous 2 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured, such as basal cell skin cancer, or carcinoma in situ of the breast.

4. Brain/central nervous system (CNS) metastases.

5. Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent

6. Active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 4 weeks prior to the first dose of investigational product.

7. Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.

8. Known active hepatitis B or C infections (known positive hepatitis B surface antigen [HBsAg] result or positive hepatitis C virus [HCV] antibody with detectable HCV ribonucleic acid [RNA] results).

9. Active or prior documented autoimmune disease that may relapse.

10. History of interstitial lung disease or noninfectious pneumonitis, except for those induced by radiation therapies.

11. Patients with clinically significant cardio-cerebrovascular disease.

12. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of toxicities not considered a safety risk.

13. History of severe hypersensitivity reactions to other mAbs.

14. Prior allogeneic stem cell transplantation or organ transplantation.

15. Known allergy or reaction to any component of the AK104 formulation.

16. Receipt of the following treatments or procedures: anticancer small molecule targeted agent within 2 weeks, radiation therapy within 2 weeks, other anticancer therapy within 4 weeks, any major surgery within 4 weeks, any other investigational product or procedure within 4 weeks, or agents with immunomodulatory effect within 2 weeks prior to the first dose of investigational product.

17. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily doses of prednisone or equivalent) or other immunosuppressive medications within 14 days prior to the first dose of investigational product.

18. Receipt of live attenuated vaccines within 30 days prior to the first dose of investigational product.

19. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).

20. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Akesobio Australia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Randall, MD

Role: STUDY_CHAIR

Virginia Commonwealth University

Locations

Womens Cancer Research Foundation

Newport Beach, California, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

BRCR Medical Center

Plantation, Florida, United States

Augusta University Medical Center

Augusta, Georgia, United States

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

Maryland Oncology Hematology (Plum Orchard)

Silver Spring, Maryland, United States

Monter Cancer Center

Lake Success, New York, United States

The Blavatnik Family - Chelsea Medical Center at Mount Sinai

New York, New York, United States

Oncology Hematology Care Inc

Cincinnati, Ohio, United States

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, United States

Chattanooga's Program In Women's Oncology

Chattanooga, Tennessee, United States

Tennessee Oncology - Centennial Clinic

Nashville, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, United States

Lyndon B. Johnson Hospital (MD Anderson)

Houston, Texas, United States

Texas Oncology (Woodlands)

The Woodlands, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Pacific Gynecology Specialists, P. C.

Seattle, Washington, United States

Monash Health

Clayton, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Ashford Cancer Centre Research

Adelaide, , Australia

Blacktown Hospital

Blacktown, , Australia

ICON Cancer Centre

Brisbane, , Australia

Auckland City Hospital

Grafton, Auckland, New Zealand

Countries

United States; Australia; New Zealand

Other Identifiers

AK104-201-AU

Identifier Type: -

Identifier Source: org_study_id