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NCT06105008Not yet recruiting

Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer

An Randomized, Open-label, Multicenter Phase 2 Study Comparing the Efficacy and Safety of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin Monotherapy in Subjects With Endocrine-resistant Hormone Receptor-positive, HER2-Low Unresectable Locally Advanced or Metastatic Breast Cancer
RemeGen Co., Ltd.Phase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Breast Neoplasms
Drug/Device/Intervention
Disitamab Vedotin
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
RemeGen Co., Ltd.
Location
Beijing,Nanjing,Changsha, China
Timeline & enrollment
Phase
Phase 2
Start date
Dec 20, 2023
End date
Apr 10, 2026
Enrollment
80 participants
Primary outcome

Progression-free survival (PFS), evaluated by investigator

Summary

This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001
 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal
 growth factor receptor (HER)2-low advanced breast cancer.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastMalignant neoplasm: Breast, unspecifiedBenign neoplasm of breastMalignant neoplasm: Central portion of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06105008
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06105008 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 Breast Neoplasms. Target enrollment is 80 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.