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

NCT07648823 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-06-16

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Glioblastoma (WHO-Grade IV Glioma)
  • Recurrent Glioblastoma
  • Glioblastoma (GBM)
  • Recurrent Glioblastoma IDH Wildtype

Interventions

DRUG

[177Lu]Lu-XT771

\[177Lu\]Lu-XT771 is a novel, first-in-human radiopharmaceutical designed to specifically target Carbonic Anhydrase IX (CA IX) and XII (CA XII), which are overexpressed in the glioblastoma microenvironment. Unlike systemic intravenous therapies, this intervention utilizes a highly localized delivery method: a single dose of 3-5 mCi \[177Lu\]Lu-XT771 is injected directly into the tumor resection cavity via a surgically implanted Ommaya reservoir. To ensure precise safety, two specific steps are required: 1) A mandatory pre-treatment leakage test using a \[68Ga\]Ga-XT771 tracer (4-6 mCi) with PET/CT imaging to rule out any leakage into the subcutaneous or subarachnoid spaces; and 2) The extraction of an equivalent volume of cerebrospinal fluid immediately prior to the therapeutic injection. Furthermore, to mitigate radiation-induced cerebral edema, the intervention is paired with a prophylactic regimen of oral dexamethasone (4 mg, three times daily) for 4 days.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Deling Li, M.D. · Beijing Tiantan Hospital

  • Zhaohui Zhu, M.D. · Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-20
Primary Completion
2027-06-20
Completion
2028-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07648823 on ClinicalTrials.gov