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NCT06155396 | RECRUITING | Cervical Cancer

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
Sponsor:

Co. Veregen, Ltd.

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-expressing subject with Recurrent or Metastatic Cervical Cancer

Condition or disease

Cervical Cancer

Intervention/treatment

Disitamab Vedotin

Zimberelimab

Phase

PHASE2

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-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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 116 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-01-11
Estimated Primary Completion Date : 2027-06-30
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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.
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

Location Details

NCT06155396

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

China, Anhui

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China, 233000

NOT YET RECRUITING

China, Beijing

Beijing Obstetrics and Gynecology Hospital ,Capital Medical University

Beijing, Beijing, China, 100026

NOT YET RECRUITING

China, Chongqing

Chongqing University Cancer Hospital

Chongqing, Chongqing, China, 400030

NOT YET RECRUITING

China, Guangxi

Guangxi Tumor Hospital

Nanning, Guangxi, China, 530021

NOT YET RECRUITING

China, Hunan

Hunan Cancer Hospital

Changsha, Hunan, China, 410031

NOT YET RECRUITING

China, Jiangxi

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China, 330008

NOT YET RECRUITING

China, Liaoning

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China, 110801

NOT YET RECRUITING

China, Shandong

Shandong Cancer Hospital & Institute

Women, Shandong, China, 250117

RECRUITING

China, Shanghai

Fudan University Shanghai Cancer Center

Shanghai, Shanghai, China, 200032

NOT YET RECRUITING

China, Tianjin

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin, China, 300181

NOT YET RECRUITING

China, Yunnan

Yunnan Cancer Hospital

Kunming, Yunnan, China, 650118

NOT YET RECRUITING

China, Zhejiang

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310005