Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04870177
Other study ID # AK112-203
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date March 16, 2021
Est. completion date May 2024

Study information

Verified date October 2022
Source Akeso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A phase II study to evaluate the efficacy and safety of AK112 in subjects with advanced gynecological tumors.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 270
Est. completion date May 2024
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Drug:
AK112
AK112 infusion biweekly

Locations

Country Name City State
China Chongqing University Cancer Hospital Chongqing
China Qilu Hospital of Shandong University Qilu Shandong

Sponsors (1)

Lead Sponsor Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rates (ORR) according to RECIST v1.1 in the FAS population Up to approximately 2 years
Secondary Efficacy endpoint: disease control rate (DCR) assessed according to RECIST v1.1 Up to approximately 2 years
Secondary Efficacy endpoint: duration of response (DOR) assessed according to RECIST v1.1 Up to approximately 2 years
Secondary Efficacy endpoint: time to response (TTR) assessed according to RECIST v1.1 Up to approximately 2 years
Secondary Efficacy endpoint: progression-free survival (PFS) assessed according to RECIST v1.1 Up to approximately 2 years
Secondary Efficacy endpoint: overall survival (OS) assessed according to RECIST v1.1 Up to approximately 2 years
Secondary Serum PK concentrations of AK112 in individual subjects at different time points after AK112 administration Up to approximately 2 years
Secondary Number of subjects with detectable anti-drug antibodies (ADA) Up to approximately 2 years
Secondary Percentage of subjects with detectable anti-drug antibodies (ADA) Up to approximately 2 years
Secondary Correlation between the expression of PD-L1 and the antitumor activity of AK112 in tumor tissues Up to approximately 2 years
Secondary 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 Up to approximately 2 years
Secondary 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 Up to approximately 2 years
See also
  Status Clinical Trial Phase
Completed NCT04890327 - Web-based Family History Tool N/A
Not yet recruiting NCT05467319 - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS Phase 3
Recruiting NCT05478876 - Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract N/A
Active, not recruiting NCT04899492 - Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy in Cancer Patients Scheduled for Surgery N/A
Terminated NCT03658109 - Lidocaine Infusion or Quadratus Lumborum Block and Intrathecal Morphine, Versus Intrathecal Morphine Alone Early Phase 1
Recruiting NCT05296512 - Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer Phase 2
Not yet recruiting NCT06398314 - Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors N/A
Completed NCT01679483 - Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer N/A
Completed NCT01444924 - Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery Phase 2
Recruiting NCT05053230 - A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer N/A
Recruiting NCT04534075 - Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial Phase 3
Active, not recruiting NCT04584957 - Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.) N/A
Completed NCT03292328 - Yoga for Symptoms of Nerve Damage Caused by Chemotherapy N/A
Completed NCT02459301 - A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies Phase 1
Completed NCT05131490 - Effect on Adaptation to Cancer of Mobile Application Developed for Gynecological Cancer Patients N/A
Active, not recruiting NCT03899376 - A Trial Comparing Acute Toxicity in Patients With Gynecological Cancer Treated With VMAT N/A
Not yet recruiting NCT05407987 - Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) Phase 3
Recruiting NCT05891470 - To Explore the Benefits of the MonaLisa Touch® System in Gynaecological Cancer Patients Treated by (Chemo)-RT N/A
Not yet recruiting NCT05974995 - Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer N/A
Withdrawn NCT04368130 - SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care N/A