OncoMatch/Clinical Trials/NCT06155396
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
Is NCT06155396 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Disitamab Vedotin and Zimberelimab for cervical cancer.
Treatment: Disitamab Vedotin · Zimberelimab — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Cervical Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 1+, 2+, or 3+; IHC 2+ requires FISH)
HER2-expressing...Central laboratory confirmation of HER2 expression: IHC 1+, 2+, or 3+; subjects with IHC 2+ require testing for FISH
Required: PD-L1 (CD274) expression
Central laboratory confirmation of PD-L1 expression
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy
failed at least 1 line of standard platinum-containing therapy
Cannot have received: antibody-drug conjugate
Previous treatment with other Antibody-drug conjugateantibody-coupled drugs
Cannot have received: allogeneic hematopoietic stem cell transplantation
Previous allogeneic haematopoietic stem cell transplantation
Lab requirements
Blood counts
ANC ≥1,500/µL; platelet count ≥100,000/μL; hemoglobin ≥9.0 g/dL
Kidney function
CrCl ≥50 mL/min (measured by the Cockcroft-Gault formula as applicable, or 24-hour urine)
Liver function
total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for subjects with total bilirubin >1.5 × ULN. Serum bilirubin ≤3× ULN for subjects with Gilbert's disease; ALT and AST ≤2.5× ULN without liver metastases or ≤5× ULN with liver metastases
Cardiac function
LVEF ≥50%; Grade 3 or higher heart failure excluded
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 × 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%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06155396 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate, allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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