Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Akesobio Australia Pty Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104 | Experimental | AK104 monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) assessed by Independent Radiological Review Committee (IRRC) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR assessed by Investigator | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1. | Up to 2 years |
| Disease control rate (DCR) | The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leslie Randall, MD | Virginia Commonwealth University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Womens Cancer Research Foundation | Newport Beach | California | 92663 | United States | ||
| Sylvester Comprehensive Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 2 years |
| Duration of Response (DoR) | Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. | Up to 2 years |
| Progression-free survival (PFS) | Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first. | Up to 2 years |
| Number of participants with adverse events (AEs) | From the time of informed consent signed through 30 days after the last dose, up to 2 years |
| Minimum observed concentration (Cmin) of AK104 at steady state | From first dosing date of AK104 through 30 days post last dose of AK104, up to 2 years |
| Number of subjects who develop detectable anti-drug antibodies | From first dosing date of AK104 through 90 days post last dose of AK104, up to 2 years |
| Miami |
| Florida |
| 33136 |
| United States |
| BRCR Medical Center | Plantation | Florida | 33322 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Illinois Cancer Specialists | Arlington Heights | Illinois | 60005-2380 | United States |
| Maryland Oncology Hematology (Plum Orchard) | Silver Spring | Maryland | 20904 | United States |
| Monter Cancer Center | Lake Success | New York | 11042 | United States |
| The Blavatnik Family - Chelsea Medical Center at Mount Sinai | New York | New York | 10011 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | United States |
| Oklahoma Cancer Specialists and Research Institute, LLC | Tulsa | Oklahoma | 74146 | United States |
| Chattanooga's Program In Women's Oncology | Chattanooga | Tennessee | 37403 | United States |
| Tennessee Oncology - Centennial Clinic | Nashville | Tennessee | 37203 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Texas Oncology-Fort Worth Cancer Center | Fort Worth | Texas | 76104 | United States |
| Lyndon B. Johnson Hospital (MD Anderson) | Houston | Texas | 77026 | United States |
| Texas Oncology (Woodlands) | The Woodlands | Texas | 77380 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Pacific Gynecology Specialists, P. C. | Seattle | Washington | 98104 | 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 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided