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

Sponsor
Beijing Tiantan Hospital
Study ID
NCT07648823
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • [177Lu]Lu-XT771 — DRUG
    \[177Lu\]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.

Study Details

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.

Key Dates

First listed
Jun 15, 2026
Start date
Jun 20, 2026
Status verified
Jun 2026
Primary completion
Jun 20, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: [177Lu]Lu-XT771
    All eligible participants with recurrence of glioblastoma will be assigned to this single experimental arm. Participants will receive a single-dose locoregional injection of 3-5 mCi of the investigational radiopharmaceutical, \[177Lu\]Lu-XT771. The drug will be administered directly into the tumor resection cavity via a surgically implanted Ommaya reservoir. Prior to the therapeutic injection, a leakage test using a \[68Ga\]Ga-XT771 tracer (4-6 mCi) will be performed to ensure proper reservoir function and safety. Additionally, to prevent cerebral edema, participants will receive a prophylactic course of oral dexamethasone (4 mg, 3 times daily), starting 24 hours prior to the \[177Lu\]Lu-XT771 injection and continuing for a total of 4 days. Following the administration, participants will be isolated until radioactivity levels reach safe discharge standards and will undergo serial SPECT/CT imaging for radiation dosimetry assessments.

Primary Outcome Measure

Radiation Dosimetry [ Time Frame: 30 minutes, 2 hours, 24 hours, 48 hours, 72 hours, and 5-7 days post-injection ]

Central Contacts

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