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Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer - Trial NCT06105008

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.

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NCT06105008
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06105008
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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

Study Focus

Breast Neoplasms

Disitamab Vedotin

Interventional

drug

Sponsor & Location

RemeGen Co., Ltd.

Beijing,Nanjing,Changsha, China

Timeline & Enrollment

Phase 2

Dec 20, 2023

Apr 10, 2026

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 breast
Malignant neoplasm of breast
Malignant neoplasm: Breast, unspecified
Benign neoplasm of breast
Malignant neoplasm: Central portion of breast

Data Source

ClinicalTrials.gov

NCT06105008

Non-Device Trial