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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 - Trial NCT06155396

Access comprehensive clinical trial information for NCT06155396 through Pure Global AI's free database. This Phase 2 trial is sponsored by RemeGen Co., Ltd. and is currently Not yet recruiting. The study focuses on Cervical Cancer. Target enrollment is 116 participants.

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NCT06155396
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06155396
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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 Vedicilumab for Injection 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

Study Focus

Cervical Cancer

Disitamab Vedotin

Interventional

drug

Sponsor & Location

RemeGen Co., Ltd.

Bengbu,Beijing,Chongqing,Nanning,Changsha,Nanchang,Shenyang,Jinan,Shanghai,Tianjin,Kunming,Hangzhou, China

Timeline & Enrollment

Phase 2

Dec 08, 2023

Dec 31, 2027

116 participants

Primary Outcome

Safety run-in ๏ผšSafety(adverse event),Dose extension period ๏ผšObjective Response Rate (ORR)

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

ICD-10 Classifications

Severe cervical dysplasia, not elsewhere classified
Mild cervical dysplasia
Moderate cervical dysplasia
Carcinoma in situ: Cervix, unspecified
Cervical root disorders, not elsewhere classified

Data Source

ClinicalTrials.gov

NCT06155396

Non-Device Trial