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
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy,safety of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer
This is a Phase II, Single-Arm ,multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer.The HER2-expressing is defined as: the HER2 IHC 3+ or 2+, or 1+.subjects with IHC 2+ require testing for FISH.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disitamab Vedotin + Zimberelimab | Experimental | Disitamab Vedotin(RC48-ADC)with Zimberelimab arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disitamab Vedotin | Drug | 2.0 mg/kg IV every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety run-in :Safety(adverse event) | to evaluate safety including adverse event rate and adverse event grade. | Up to approximately 2 years |
| Dose extension period :Objective Response Rate (ORR) | The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed | Up to approximately 2 years |
| Duration of Response (DOR) |
Not provided
Inclusion Criteria:
a)Patients with histologically confirmed HER2-expressing recurrent or metastatic cervical cancer who have failed at least 1 line of standard platinum-containing therapy ; b) Not suitable for surgery or radiotherapy;
Voluntarily agreed to participate in the study and signed an informed consent form.
Female, age ≥ 18 years
Expected survival ≥ 12 weeks
Central laboratory confirmation of HER2 expression: IHC 1+, 2+, or 3+; subjects with IHC 2+ require testing for FISH.
Central laboratory confirmation of PD-L1 expression
Measurable disease according to RECIST 1.1 standard
ECOG physical condition 0 or 1 point
Adequate organ function, criteria should be met during the screening period
Female subjects should be surgically sterilised, post-menopausal or agree to use at least one medically approved contraceptive method during and for 6 months after the end of the study treatment period, must have had a negative blood pregnancy test within 7 days prior to study entry, and must be non-lactating.
Willingness and ability to comply with trial and follow-up procedure arrangements.
Exclusion Criteria:
Have central nervous system metastases and/or carcinomatous meningitis.
Received anti-tumour therapy or participated in another clinical study treatment within 4 weeks prior to the start of study treatment.
Toxicity due to previous antineoplastic therapy has not recovered to NCI-CTCAE (version 5.0) grade 0-1.
Major surgery with incomplete recovery within 4 weeks prior to start of study dosing.
Serum virology examination (based on the normal value of the research center) :
Have received a live or live attenuated vaccine within 4 weeks prior to the start of study dosing; or plan to receive any vaccine during the study period
Grade 3 or higher heart failure
History of gastrointestinal perforation and/or fistula within the previous 6 months
Serious arterial/venous thrombotic event or cardiovascular accident within 1 year prior to study drug administration
Presence of active or progressive infection requiring systemic therapy, with severe infection within 4 weeks prior to first dose;
Active TB.
Presence of systemic disease not under stable control as judged by the investigator.
History of interstitial pneumonia, obstructive lung disease, drug-induced pneumonia, radiation pneumonia, idiopathic pneumonia or active pneumonia.
Clinically relevant pyelonephrosis cannot be alleviated by ureteral stents or percutaneous drainage.
Presence of active autoimmune disease requiring systemic therapy within 2 years prior to the start of study drug administration, allowing for relevant alternative therapy.
Other malignancy within 5 years prior to start of study drug administration.
Previous allogeneic haematopoietic stem cell transplantation.
Previous treatment with other Antibody-drug conjugateantibody-coupled drugs.
Known hypersensitivity to the drug vedicilizumab for injection and its components or to Zimberelimab injection and other monoclonal antibodies.
Have any other disease, metabolic abnormality, physical examination abnormality or laboratory test abnormality.
Estimated lack of patient adherence to participate in this clinical study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianmin Fang, Ph.D | Contact | +8610-58075763 | Jianminfang@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Fang, Ph.D | RemeGen Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of bengbu medical college | Not yet recruiting | Bengbu | Anhui | 233000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Zimberelimab | Drug | 240mg IV every 2 weeks |
|
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
| Up to approximately 2 years |
| Disease Control Rate(DCR) | Proportion of patients whose tumors shrank or stabilized for a certain period of time | Up to approximately 2 years |
| Progression-free survival (PFS), evaluated by the investigator | Progression-free survival (PFS) refers to the time from the date of first administration to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard. | Up to approximately 2 years |
| Overall survival (OS) | Overall survival (OS) refers to the time from the date of first administration to the date of death of the subject. | Up to approximately 2 years |
| Beijing Obstetrics and Gynecology Hospital ,Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100026 | China |
|
| Chongqing University Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | 400030 | China |
|
| Guangxi Tumor Hospital | Not yet recruiting | Nanning | Guangxi | 530021 | China |
|
| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410031 | China |
|
| Jiangxi Maternal and Child Health Hospital | Not yet recruiting | Nanchang | Jiangxi | 330008 | China |
|
| Liaoning Cancer Hospital & Institute | Not yet recruiting | Shenyang | Liaoning | 110801 | China |
|
| Shandong Cancer Hospital & Institute | Not yet recruiting | Jinan | Shandong | 250117 | China |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300181 | China |
|
| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | 650118 | China |
|
| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310005 | China |
|
| 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
| ID | Term |
|---|---|
| C000722994 | disitamab vedotin |
| C000719848 | zimberelimab |
Not provided
Not provided
Not provided