RecruitingEarly Phase 1NCT07340424

A Prospective, Open-label, Single-arm, Exploratory Clinical Trial to Evaluate the Safety and Tolerability of 225Ac-TR2205 Injection in Patients With Triple-negative Breast Cancer.


Sponsor

Xiaorong Sun

Enrollment

15 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, single-center, single-arm, open-label research. It evaluates the safety and tolerability of 225Ac-TR2205 in patients with triple-negative breast cancer (TNBC), and assesses its radiation dosimetry and initial efficacy.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing the safety of a new radioactive drug called 225Ac-TR2205 in women with metastatic triple-negative breast cancer — an aggressive form of breast cancer that lacks the three most common treatment targets. This type of therapy uses a radioactive particle attached to a molecule that seeks out tumour cells. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with triple-negative breast cancer that has spread (metastatic) - You have already received at least 2 systemic treatments (at least one for metastatic disease) - Your cancer can be measured on a scan - You are in reasonably good physical condition (ECOG 0–1) - You are not pregnant and agree to use effective contraception **You may NOT be eligible if...** - You have significant unresolved side effects from previous treatments - Your general health does not meet the minimum requirements - You are breastfeeding or pregnant 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

DRUG225Ac-TR2205 Injection

Patients will receive 225Ac-TR2205 injection administration at an interval of 8 weeks between each dose.


Locations(1)

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

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NCT07340424