RecruitingPhase 1Phase 2NCT06508216

A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer

A Phase Ib/II, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer


Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

50 participants

Start Date

Jul 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Choice Of the Most Active Strategies for Short term recurring Triple Negative Breast Cancer: A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and anti-tumor activity of novel therapeutics in patients with early relapsed metastatic triple-negative breast cancer


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new investigational drug combinations in patients with triple-negative breast cancer (TNBC) — a type of breast cancer that lacks estrogen, progesterone, and HER2 receptors — that has come back or spread after prior treatment. It is a Phase I study focused on finding the safest and most effective dose of these new treatments. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with advanced or metastatic triple-negative breast cancer (HER2-negative and hormone receptor-negative) - Your cancer has relapsed early (within 6–12 months) after prior treatment including chemotherapy and a PARP inhibitor - You are in reasonably good overall health **You may NOT be eligible if...** - Your cancer is still potentially curable with surgery - You have not received certain required prior treatments - You have significant heart, liver, kidney, 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

DRUGDato-DXd

Patients in module 1 \& 2 will receive Datopotamab Deruxtecan (Dato-DXd) 6mg/kg every 21 days

DRUGDurvalumab

Patients in module 2 only will receive Durvalumab 1120mg every 21 days


Locations(1)

Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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

Visit

NCT06508216


Related Trials