RecruitingPhase 2NCT06793332

BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC

Prospective, One-arm, Phase II Clinical Study of Ivoximab Combined With TROP2 ADC in the Treatment of Brain Metastases in Triple-negative Breast Cancer

Sponsor

Fudan University

Enrollment

39 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

Triple Negative Breast Cancer(TNBC)Brain Metastases

Summary

This study is a single-center, prospective, single-arm clinical trial, which intends to enroll patients with triple-negative breast cancer with brain metastases to receive ivonescimab combined with TROP2 ADC (such as sacituzumab govitecan) treatment until disease progression, intolerable toxicity, withdrawal of informed consent, or the investigator deems it necessary to discontinue the medication, and to collect data on the drug's efficacy and safety.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — ivonescimab (a dual immune and anti-angiogenesis drug) and a type of chemotherapy targeted at a protein called Trop2 — in women with triple-negative breast cancer that has spread to the brain. Triple-negative breast cancer lacks three hormone receptors and is often harder to treat. **You may be eligible if...** - You are 18–70 years old with triple-negative breast cancer that has spread and stopped responding to taxane chemotherapy - Your cancer has spread to the brain, with at least one brain lesion that has not been treated with radiation and is at least 1 cm in size - Your general health status is adequate (ECOG 0–2) **You may NOT be eligible if...** - Your breast cancer is not triple-negative - Your brain lesions have all been treated with radiation without signs of progression - You have significant heart, liver, or other organ problems 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIvonescimab Combined With TROP2 ADC

Ivonescimab: 20 mg/kg, ivggt, day 1, every 3 weeks; Sacituzumab govitecan: 10 mg/kg, ivggt, day 1 and day 8, every 3 weeks;

Locations(1)

Fudan University Shanghai Cancer center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06793332

Related Trials

Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies

NCT0578692427 locations

Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases

NCT048999082 locations

A Nurse-Led, Coping and Supportive Intervention for Patients With Triple-Negative Breast Cancer

NCT075133111 location

First-in-human, Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) Alone or in Combination With Pembrolizumab in Stage II-- III Triple Negative Breast Cancer Following Standard Therapy ( VITAL-TNBC )

NCT076522422 locations

A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain

NCT054190767 locations