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 (May 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
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)
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.
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