Clinical Trial · NCT07648823

Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent Glioblastoma

Overview

The primary objective of this study is to evaluate the dosimetry, safety, and tolerability of the investigational radiopharmaceutical \[177Lu\]Lu-XT771 in patients with recurrent glioblastoma, an aggressive form of brain cancer. \[177Lu\]Lu-XT771 is designed to specifically target and deliver beta radiation directly to tumor cells that overexpress carbonic anhydrase IX and XII (CA IX and CA XII). This early-phase, investigator-initiated trial will enroll a small group of approximately 3-5 patients, each receiving a single dose of \[177Lu\]Lu-XT771. The drug will be administered locoregionally via an implanted Ommaya reservoir, directly into the tumor cavity. Following administration, patients will be closely monitored using single-photon emission computed tomography/computed tomography (SPECT/CT) to assess the biodistribution of the drug and to quantify the absorbed radiation dose to both the tumor and normal organs. The study will also document all adverse events to characterize the safety profile of the treatment and will provide a preliminary assessment of its anti-tumor activity, as measured by progression-free survival. The information gathered from this exploratory study will be used to determine the recommended safe starting dose for future Phase I clinical trials.

Sponsor

Beijing Cancer Hospital

Phase

Early Phase 1

Contacts

Deling Li, M.D. (PRINCIPAL_INVESTIGATOR)

Deling Li, M.D. (CONTACT)

lideling@bjtth.org

Zhaohui Zhu, M.D. (PRINCIPAL_INVESTIGATOR)

Li'ao Wang, M.D. (CONTACT)

wangliao17@163.com

+86 15001171671

ClinicalTrials.gov

NCT07648823

Eligibility

Inclusion

Life expectancy of at least 3 months.
Histologically confirmed glioblastoma (based on the 2021 WHO Classification of Tumors of the Central Nervous System, 5th edition), and confirmed CA IX/CA XII positive by histology or \[68Ga\]Ga-XT771 PET/CT.
Age ≥ 18 and ≤ 80 years old.
1. Subject has fully understood the study and voluntarily signed the informed consent form.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

Exclusion

Underwent major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to dosing, or expected to require elective surgery during the study period.
1. Received anti-tumor treatments (including radiotherapy, chemotherapy, biological therapy, endocrine therapy, targeted therapy, etc.) within 4 weeks prior to dosing. Exceptions: (1) immunotherapy, nitrosoureas, or mitomycin C within 6 weeks prior to dosing; (2) oral fluorouracils and small molecule targeted drugs within 2 weeks or 5 half-lives (whichever is longer) prior to dosing; (3) Traditional Chinese Medicine with anti-tumor indication within 2 weeks prior to dosing; (4) cranial radiotherapy within 3 months prior to dosing.
Known or suspected allergy to the study drug or its analogue components.
Received any other unapproved investigational drug within 4 weeks prior to dosing.
Inability to undergo contrast-enhanced MRI scans (e.g., due to pacemakers, contrast agent allergy).