Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer | Biological: GB226 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Clinical Study to Evaluate the Efficacy and Safety of GB226 in Treatment of Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive Who Failed in Platinum-based Chemotherapy |
Actual Study Start Date : | May 23, 2019 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | July 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: GB226
Geptanolimab Injection,3mg/kg once per 2 weeks
|
Biological: GB226
GB226 is administrated at the dose of 3mg/kg, once per 2 weeks (±3 days), and distributed in 100ml of 0.9% sodium chloride solution. The concentration of GB226 shall be strictly controlled at 1mg/ml~10mg/ml, the duration is 60 min (±10 min) for the first infusion of the drug, and can be reduced to 30 min (±10 min) for the subsequent infusion of the drug if there is infusion related adverse reaction.
Other Name: Geptanolimab
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
9. The values of laboratory tests performed during screening shall meet the following criteria:
Blood routine test (No blood transfusion within 14 days before test, no use of G-CSF, no use of drug correction);
Biochemical test
Exclusion Criteria:
Contact: Shawn Yu, master | 86-010-65260820 | shawn.yu@genorbio.com |
China, Beijing | |
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting |
Beijing, Beijing, China, 100021 | |
Contact: Lingying Wu 0086-010-67781331,china wulingying@csco.org.cn | |
Principal Investigator: Wu Lingying, Medical PhD |
Principal Investigator: | Lingying Wu, Doctor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | December 27, 2018 | ||||
First Posted Date ICMJE | January 18, 2019 | ||||
Last Update Posted Date | March 3, 2021 | ||||
Actual Study Start Date ICMJE | May 23, 2019 | ||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Objective response rate, ORR [ Time Frame: 2 years ] To evaluate the efficacy of GB226 as defined by objective response rate, in patients with recurrent or metastatic cervical cancer.
|
||||
Original Primary Outcome Measures ICMJE |
Objective response rate [ Time Frame: Up to 104 weeks since the last patient was randomized. ] Objective response rate
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive | ||||
Official Title ICMJE | Phase II Clinical Study to Evaluate the Efficacy and Safety of GB226 in Treatment of Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive Who Failed in Platinum-based Chemotherapy | ||||
Brief Summary | This study is a multi-center, prospective, open-label, single-arm phase II clinical study to evaluate the efficacy, safety and immunogenicity of GB226 in treatment of recurrent or metastatic cervical cancer patients with PD-L1 positive who failed in platinum-based chemotherapy. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Cervical Cancer | ||||
Intervention ICMJE | Biological: GB226
GB226 is administrated at the dose of 3mg/kg, once per 2 weeks (±3 days), and distributed in 100ml of 0.9% sodium chloride solution. The concentration of GB226 shall be strictly controlled at 1mg/ml~10mg/ml, the duration is 60 min (±10 min) for the first infusion of the drug, and can be reduced to 30 min (±10 min) for the subsequent infusion of the drug if there is infusion related adverse reaction.
Other Name: Geptanolimab
|
||||
Study Arms ICMJE | Experimental: GB226
Geptanolimab Injection,3mg/kg once per 2 weeks
Intervention: Biological: GB226
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 2022 | ||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03808857 | ||||
Other Study ID Numbers ICMJE | Gxplore-008 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Genor Biopharma Co., Ltd. | ||||
Study Sponsor ICMJE | Genor Biopharma Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Genor Biopharma Co., Ltd. | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |