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Updated May 2026 · ClinicalTrials.gov

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

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 (NCT06155396) is a Phase 2 interventional studying Cervical Cancer, sponsored by RemeGen Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Cervical Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 116 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cervical Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

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.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06155396), the sponsor (RemeGen Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06155396 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06155396?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06155396?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06155396. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06155396. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.