Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent Glioblastoma (NCT07648823) | Clinical Trial Compass
RecruitingEarly Phase 1
Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent Glioblastoma
China5 participantsStarted 2026-06-20
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject has fully understood the study and voluntarily signed the informed consent form.
. Age ≥ 18 and ≤ 80 years old.
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
. 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.
. Histologically confirmed recurrence of glioblastoma following prior treatments.
. Suitable for Ommaya reservoir placement and meets the conditions for drug administration, as judged by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial measuring radiation dosimetry and safety of a radioactive drug called [177Lu]Lu-XT771 — what does that mean for how much is actually known about whether it works, and is there a standard treatment I should try first before considering something this early-stage?
2Since the trial is specifically looking at how radiation from this drug spreads through the body, does my tumor's location or size affect how much radiation exposure my healthy brain tissue might receive, and what are the risks I should understand before agreeing to that?
3The trial is for recurrent glioblastoma that is IDH wildtype — can you confirm whether my tumor fits that specific molecular profile, and would that affect whether this trial is even worth discussing as an option for me?
4Because this is a Phase 1 study focused on safety and adverse events, what are the most serious side effects that have been seen with lutetium-based radioligand therapies in other cancers, and how would my care team monitor me if something serious happened?
5Given that this trial is still in early recruitment, what would my participation actually involve in terms of hospital visits, radiation precautions at home, and how that might affect my family or daily life during treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiation Dosimetry
Timeframe: 30 minutes, 2 hours, 24 hours, 48 hours, 72 hours, and 5-7 days post-injection
2
Incidence and severity of adverse events and incidence of serious adverse events
Timeframe: From the time of informed consent up to 30 days after the last dose
. Tumor resection cavity volume between 2.5 and 25 cm\^3.
Exclusion criteria
. 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.
. Received any other unapproved investigational drug within 4 weeks prior to dosing.
. 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.
. Known or suspected allergy to the study drug or its analogue components.
. Inability to undergo contrast-enhanced MRI scans (e.g., due to pacemakers, contrast agent allergy).
. Presence of active or uncontrolled infections requiring systemic intravenous treatment, or unexplained fever \>38.5°C during the screening period or before dosing.
. Presence of severe coagulation disorders or evidence of significant bleeding risk; history of gastrointestinal bleeding; any Grade ≥2 bleeding event (CTCAE v5.0) within the past 6 months.
. Active Hepatitis B (HBsAg positive and HBV-DNA \> 500 IU/mL or above the lower limit of detection of the study center) or Active Hepatitis C (HCV antibody positive and HCV-RNA \> the lower limit of detection of the study center).