Tests disitamab vedotin with zimberelimab in HER2-expressing cervical cancer that has returned or spread
Tests disitamab vedotin with zimberelimab in adults with HER2-expressing cervical cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Beijing, Bengbu, Changsha, Chongqing, Hangzhou, Jinan, Kunming, Nanchang, Nanning, Shanghai, Shenyang, and Tianjin, ChinaSee the 12 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with cervical cancer that has come back or spread, shows HER2, and did not respond to at least one platinum-based treatment.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Recurrent or metastatic cervical cancer with HER2 expression (IHC 1+, 2+ or 3+; IHC 2+ also needs a FISH test), PD-L1 expression confirmed, measurable disease by RECIST 1.1, and not able to have surgery or radiotherapy
- Earlier treatment
- Must have had at least 1 line of standard platinum-containing therapy that failed. Must not have had other antibody-drug conjugate drugs, anti-tumour therapy within 4 weeks, or a stem-cell transplant from a donor.
- Biomarker or test result
- HER2 expression IHC 1+, 2+ or 3+ confirmed by a central laboratory (FISH test needed for IHC 2+); PD-L1 expression confirmed by a central laboratory
Main reasons for not taking part
- Cancer spread to the brain or its lining
- Positive test for hepatitis B, hepatitis C (with positive HCV RNA) or HIV
- Active infection needing systemic treatment, or active TB
- History of lung inflammation or interstitial pneumonia
- Another cancer within the last 5 years
Read by machine on 9 November 2026.
Where in China
- Beijing Obstetrics and Gynecology Hospital, Capital Medical UniversityBeijing, ChinaNot yet recruiting
- The First Affiliated Hospital of Bengbu Medical CollegeBengbu, ChinaNot yet recruiting
- Hunan Cancer HospitalChangsha, ChinaNot yet recruiting
- Chongqing University Cancer HospitalChongqing, ChinaNot yet recruiting
- Zhejiang Cancer HospitalHangzhou, ChinaNot yet recruiting
- Shandong Cancer Hospital & instituteJinan, ChinaNot yet recruiting
- Yunnan Cancer HospitalKunming, ChinaNot yet recruiting
- Jiangxi maternal and child health hospitalNanchang, ChinaNot yet recruiting
- Guangxi Tumor HospitalNanning, ChinaNot yet recruiting
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
- Liaoning Cancer Hospital & InstituteShenyang, ChinaNot yet recruiting
- Tianjin Medical University Cancer Institute and HospitalTianjin, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- RemeGen Co., Ltd.
- Trial code
- NCT06155396
- Record updated
- 28 February 2024
- Original description
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 CancerRead full original descriptionShow less
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
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
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: 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; 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; 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; 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; Grade 3 or higher heart failure; 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; Known hypersensitivity to the drug vedicilizumab for injection and its components or to Zimberelimab injection and other monoclonal antibodies; 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 any other disease, metabolic abnormality, physical examination abnormality or laboratory test abnormality; Have central nervous system metastases and/or carcinomatous meningitis; Active TB; Clinically relevant pyelonephrosis cannot be alleviated by ureteral stents or percutaneous drainage; Estimated lack of patient adherence to participate in this clinical study.