RecruitingPhase 2NCT06642545

Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer

A Randomized, Open-label, Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With RC148 Versus Albumin-bound Paclitaxone Alone or in Combination With Toripalimab in Subjects With HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer


Sponsor

RemeGen Co., Ltd.

Enrollment

40 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatment regimens for people with HER2-low, hormone receptor-negative breast cancer that has spread or cannot be surgically removed. It tests a combination of two targeted antibody-drug conjugates (disitamab vedotin + RC148) against a standard chemotherapy regimen. **You may be eligible if...** - You have unresectable locally advanced or metastatic breast cancer - Your tumor is confirmed HER2-low and hormone receptor-negative - You have not previously received anti-HER2 treatment or immunotherapy - Your cancer has measurable areas on imaging - Your organ function and blood counts meet required levels - Your general health is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have previously received anti-HER2 therapy or immunotherapy in the metastatic setting - You have active, untreated brain metastases - You have significant heart disease or active lung disease - You have active hepatitis B, C, or HIV - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDisitamab Vedotin

Disitamab Vedotin 2.0mg/kg,intravenous infusion, every 2 weeks

DRUGRC148

20mg/kg, intravenous infusion, once every 2 weeks

DRUGAlbumin-bound Paclitaxone

125 mg/m2,intravenous infusion, D1-8, every 3 weeks

DRUGToripalimab

240mg,intravenous infusion, once every 3 weeks


Locations(1)

Cance Hosoltal Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06642545


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