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RECRUITINGPhase 2INTERVENTIONAL

A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer

A Single-Arm, Open- Label, Multicenter Phase II Study 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 1. a)Patients with diagnosed by tissue sample (biopsy-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; 2. Voluntarily agreed to participate in the study and signed an willing to sign a consent form form. 3. Female, age ≥ 18 years 4. Expected survival ≥ 12 weeks 5. Central laboratory confirmation of HER2 expression: IHC 1+, 2+, or 3+; subjects with IHC 2+ require testing for FISH. 6. Central laboratory confirmation of PD-L1 expression 7. Measurable disease according to RECIST 1.1 standard 8. ECOG physical condition 0 or 1 point 9. your organs (liver, kidneys, etc.) are working well enough based on blood tests, criteria should be met during the screening period 1. white blood cell count (ANC) at least 1,500/µL 2. platelet count ≥100,000/μL 3. blood count (hemoglobin) at least 9.0 g/dL 4. total bilirubin ≤1.5 × upper limit normal (ULN) OR direct bilirubin ≤ULN for subjects with total bilirubin \>1.5 × ULN. Serum bilirubin ≤3× ULN for subjects with Gilbert's disease 5. CrCl ≥50 mL/min (measured by the Cockcroft-Gault formula as applicable, or 24-hour urine). 6. ALT and AST ≤2.5× ULN without liver metastases or ≤5× ULN with liver metastases 7. LVEF ≥\>50% 10. 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. 11. Willingness and ability to comply with trial and follow-up procedure arrangements. Who Should NOT Join This Trial: 1. Have cancer that has spread to the brain and/or carcinomatous meningitis. 2. Received anti-tumour therapy or participated in another clinical study treatment within 4 weeks prior to the start of study treatment. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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; 2. Voluntarily agreed to participate in the study and signed an informed consent form. 3. Female, age ≥ 18 years 4. Expected survival ≥ 12 weeks 5. Central laboratory confirmation of HER2 expression: IHC 1+, 2+, or 3+; subjects with IHC 2+ require testing for FISH. 6. Central laboratory confirmation of PD-L1 expression 7. Measurable disease according to RECIST 1.1 standard 8. ECOG physical condition 0 or 1 point 9. Adequate organ function, criteria should be met during the screening period 1. ANC ≥1,500/µL 2. platelet count ≥100,000/μL 3. hemoglobin ≥9.0 g/dL 4. total bilirubin ≤1.5 × upper limit normal (ULN) OR direct bilirubin ≤ULN for subjects with total bilirubin \>1.5 × ULN. Serum bilirubin ≤3× ULN for subjects with Gilbert's disease 5. CrCl ≥50 mL/min (measured by the Cockcroft-Gault formula as applicable, or 24-hour urine). 6. ALT and AST ≤2.5× ULN without liver metastases or ≤5× ULN with liver metastases 7. LVEF ≥\>50% 10. 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. 11. Willingness and ability to comply with trial and follow-up procedure arrangements. Exclusion Criteria: 1. Have central nervous system metastases and/or carcinomatous meningitis. 2. Received anti-tumour therapy or participated in another clinical study treatment within 4 weeks prior to the start of study treatment. 3. Toxicity due to previous antineoplastic therapy has not recovered to NCI-CTCAE (version 5.0) grade 0-1. 4. Major surgery with incomplete recovery within 4 weeks prior to start of study dosing. 5. Serum virology examination (based on the normal value of the research center) : 1. HBsAg test results were positive, and HBV DNA copy number was positive; 2. HCVAb test results were positive (HCV RNA PCR test results were negative only to be included in this study); 3. HIVAb tested positive 6. 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 7. Grade 3 or higher heart failure 8. History of gastrointestinal perforation and/or fistula within the previous 6 months 9. Serious arterial/venous thrombotic event or cardiovascular accident within 1 year prior to study drug administration 10. Presence of active or progressive infection requiring systemic therapy, with severe infection within 4 weeks prior to first dose; 11. Active TB. 12. Presence of systemic disease not under stable control as judged by the investigator. 13. History of interstitial pneumonia, obstructive lung disease, drug-induced pneumonia, radiation pneumonia, idiopathic pneumonia or active pneumonia. 14. Clinically relevant pyelonephrosis cannot be alleviated by ureteral stents or percutaneous drainage. 15. Presence of active autoimmune disease requiring systemic therapy within 2 years prior to the start of study drug administration, allowing for relevant alternative therapy. 16. Other malignancy within 5 years prior to start of study drug administration. 17. Previous allogeneic haematopoietic stem cell transplantation. 18. Previous treatment with other Antibody-drug conjugateantibody-coupled drugs. 19. Known hypersensitivity to the drug vedicilizumab for injection and its components or to Zimberelimab injection and other monoclonal antibodies. 20. Have any other disease, metabolic abnormality, physical examination abnormality or laboratory test abnormality. 21. Estimated lack of patient adherence to participate in this clinical study.

Treatments Being Tested

DRUG

Disitamab Vedotin

2.0 mg/kg IV every 2 weeks

DRUG

Zimberelimab

240mg IV every 2 weeks

Locations (12)

The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Beijing Obstetrics and Gynecology Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Guangxi Tumor Hospital
Nanning, Guangxi, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Shandong Cancer Hospital & Institute
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China