- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04870177
Study of AK112 in the Treatment of Advanced Gynecological Tumors
October 8, 2022 updated by: Akeso
Phase II Study of AK112 (Anti-PD-1 and VEGF Bi-specific Antibody) in the Treatment of Advanced Gynecological Carcinoma
A phase II study to evaluate the efficacy and safety of AK112 in subjects with advanced gynecological tumors.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
270
Phase
- Phase 2
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
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Chongqing, China, 400030
- Chongqing University Cancer Hospital
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Shandong
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Qilu, Shandong, China, 250012
- Qilu Hospital of Shandong University
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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
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Be able and willing to provide written informed consent
- 18 to 75 years old of age during enrollment
- Has ECOG performance status of 0 or 1
- Has a life expectancy of at least 3 months
- Confirmed diagnosis of advanced gynaecological neoplasm
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator
- Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy
- Has adequate organ functions (e.g hematology, renal, hepatic and coagulation)
- All female subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment
- Be able and willing to comply with all requirements of study participation (including all study procedures)
Exclusion Criteria:
- Known history of other malignancy (in the last 5 years) except localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ, breast carcinoma in situ that has undergone curative therapy and breast carcinoma that has not recurred for > 3 years after radical surgery
- Is currently participating in a study of an investigational agent or using an investigational device 4 weeks prior to first administration of study drug
- For patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, prior abdominal and pelvic radiation therapy was performed
- For recurrent/metastatic endometrial carcinoma, subjects had carcinosarcomas (malignant mixed Mullerian tumors), endometrial leiomyosarcomas or other high-grade sarcomas, or endometrial stromal sarcomas
- Ovarian carcinoma of non-epithelial origin, fallopian tube cancer, primary peritoneal carcinoma (e.g., germ cell tumor); Ovarian neoplasms with low malignancy potential (e.g. borderline neoplasms)
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
- Previous history of immunodeficiency; HIV antibody positive; Current long-term use of systemic corticosteroids or other immunosuppressants
- Severe infection, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia, occurs within 4 weeks prior to the first administration of the study drug; Active infection with systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within two weeks prior to first administration of study drug
- Untreated active hepatitis B subjects; subjects with hepatitis B are required to receive anti-HBV therapy during the study period; active hepatitis C subjects
- Has undergone major surgery within 30 days prior to the first dose of study treatment
- Has known active central nervous system (CNS) metastases
- Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure, or vascular disease requiring hospitalization (such as aortic aneurysm at risk of rupture), or other cardiac impairment (such as poorly controlled arrhythmias, myocardial ischemia) that may affect study drug safety evaluation within 12 months prior to first administration of study drug
- Previous history of abdominal fistula or gastrointestinal perforation associated with anti-VEGF therapy; the imaging results revealed the invasion of intestinal wall by neoplasm during screening
- During screening, imaging or clinical findings of gastrointestinal obstruction, including incomplete obstruction
- Previous history of severe bleeding or coagulation disorders; during screening, imaging showed that the neoplasm surrounded major blood vessels or had obvious necrosis and cavitation, and the investigators believed that participation in the study might increase risk of bleeding
- Has received a live virus vaccine within 30 days prior to first administration of study drug or plan to be administered during the study period
- Has known psychiatric or substance abuse disorders
- Is pregnant, breastfeeding women
- Any prior or current disease, treatment, or laboratory test abnormality that may confound the study endpoints, interfere with subjects' full participation in the study, or may not be in their best interest to participate in this study
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Advanced gynecological neoplasms
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AK112 infusion biweekly
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rates (ORR) according to RECIST v1.1 in the FAS population
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy endpoint: disease control rate (DCR) assessed according to RECIST v1.1
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Efficacy endpoint: duration of response (DOR) assessed according to RECIST v1.1
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Efficacy endpoint: time to response (TTR) assessed according to RECIST v1.1
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Efficacy endpoint: progression-free survival (PFS) assessed according to RECIST v1.1
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Efficacy endpoint: overall survival (OS) assessed according to RECIST v1.1
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Serum PK concentrations of AK112 in individual subjects at different time points after AK112 administration
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Number of subjects with detectable anti-drug antibodies (ADA)
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Percentage of subjects with detectable anti-drug antibodies (ADA)
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Correlation between the expression of PD-L1 and the antitumor activity of AK112 in tumor tissues
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Correlation between microsatellite instability (MSI) and mismatch repair defect (DMMR) in tumor tissue samples from patients with endometrial cancer and the antitumor activity of AK112
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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The association between BRCA1/2 mutation and AK112 antitumor activity in peripheral blood samples and tumor tissues from patients with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
Time Frame: Up to approximately 2 years
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Up to approximately 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Beihua Kong, MD, Qilu Hospital of Shandong University
- Study Chair: Qi Zhou, MD, Chongqing University Cancer Hospital
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)
March 16, 2021
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
May 1, 2024
Study Registration Dates
First Submitted
April 5, 2021
First Submitted That Met QC Criteria
April 29, 2021
First Posted (Actual)
May 3, 2021
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 8, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Neoplasms
- Uterine Cervical Neoplasms
- Ovarian Neoplasms
- Endometrial Neoplasms
Other Study ID Numbers
- AK112-203
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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