Status:
RECRUITING
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
Lead Sponsor:
RemeGen Co., Ltd.
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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-expressin...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- ANC ≥1,500/µL
- platelet count ≥100,000/μL
- hemoglobin ≥9.0 g/dL
- 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
- CrCl ≥50 mL/min (measured by the Cockcroft-Gault formula as applicable, or 24-hour urine).
- ALT and AST ≤2.5× ULN without liver metastases or ≤5× ULN with liver metastases
- LVEF ≥\>50%
- 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
- 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) :
- HBsAg test results were positive, and HBV DNA copy number was positive;
- HCVAb test results were positive (HCV RNA PCR test results were negative only to be included in this study);
- HIVAb tested positive
- 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.
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06155396
Start Date
January 11 2024
End Date
December 31 2027
Last Update
February 28 2024
Active Locations (12)
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1
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China, 233000
2
Beijing Obstetrics and Gynecology Hospital ,Capital Medical University
Beijing, Beijing Municipality, China, 100026
3
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
4
Guangxi Tumor Hospital
Nanning, Guangxi, China, 530021