HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease
Status:
Not yet recruiting
Trial end date:
2026-10-01
Target enrollment:
Participant gender:
Summary
The goal of this phase II clinical trial] is to analyze the efficacy of patritumab deruxtecan
(HER3-DXd) in patients with metastatic breast cancer (MBC) or advanced non-small cell lung
cancer (aNSCLC) with active brain metastases (BM) who have received at least one line of
systemic therapy in the advanced setting, or patients with active leptomeningeal
carcinomatosis/disease (LMD) after radiotherapy from an advanced solid tumor who do not need
immediate local treatment, and have not received prior treatment with an anti-HER3 targeted
drug].
The main questions it aims to answer are:
- The intracranial objective response rate (ORR-IC) per local investigator as judged by
best central nervous system (CNS) response according to Response Assessment in
Neuro-Oncology Brain Metastases (RANO-BM) criteria of HER3-DXd in patients with active
BM from MBC (Cohort 1) and aNSCLC (Cohort 2).
- The overall survival (OS) rate at 3 months of HER3-DXd in patients with advanced solid
tumors with untreated LMD (Cohort 3).
Participants will receive HER3-DXd on day (D1) of each 21-day cycle until disease
progression, unacceptable toxicity, death, or discontinuation from the study treatment for
any other reason.
Researchers will compare historical groups to see if HER3-DXd positively impacts patient
outcomes.