Targeted radiation delivered directly to brain tumor cavity in new trial
NCT ID NCT07648823
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a single dose of a radioactive drug called [177Lu]Lu-XT771 in people with recurrent glioblastoma, an aggressive brain cancer. The drug is injected directly into the cavity left after tumor removal surgery, aiming to deliver radiation precisely to cancer cells while sparing healthy tissue. The study involves only 3-5 participants and focuses on safety, how the drug spreads in the body, and its potential to slow tumor growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [177Lu]Lu-XT771 (a radioactive drug injected into the tumor cavity)
- What this could lead to
- If successful, this approach could provide a new, targeted treatment option for recurrent glioblastoma, potentially slowing tumor growth with fewer side effects than systemic therapies.
- What could go wrong
- This is a very early, small study (only 3-5 participants) designed primarily to test safety and dosing. The treatment may not shrink tumors or improve survival, and there are risks from radiation exposure to healthy brain tissue and other organs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject has fully understood the study and voluntarily signed the informed consent form. 2. Age ≥ 18 and ≤ 80 years old. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. 4. Life expectancy of at least 3 months. 5. 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. 6. Histologically confirmed recurrence of glioblastoma following prior treatments. 7. Suitable for Ommaya reservoir placement and meets the conditions for drug administration, as judged by the investigator. 8. Tumor resection cavity volume between 2.5 and 25 cm\^3. 9. On a stable or decreasing dose of corticosteroids (≤5 mg/day of dexamethasone or equivalent) for at least 1 week prior to the first dose. 10. Toxicity from prior anti-tumor treatments (e.g., chemotherapy, radiotherapy, immunotherapy) recovered to ≤ Grade 1 (excluding alopecia). 11. Adequate organ and bone marrow function meeting the following criteria: * Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 ×10\^9/L and white blood cell (WBC) count ≥ 3 ×10\^9 /L (without growth factor support within 28 days prior to dosing); Platelet count ≥ 75 ×10\^9/L; Hemoglobin ≥ 90 g/L. * Hepatic function: Total bilirubin ≤ 1.5 × ULN (≤ 2.0 × ULN for subjects with liver metastases; ≤ 3.0 × ULN for subjects with confirmed Gilbert's syndrome); ALT and AST ≤ 3 × ULN (\< 5 × ULN for subjects with liver metastases); Albumin \> 30 g/L. * Renal function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min. * Coagulation: INR ≤ 2.0, APTT ≤ 1.5 × ULN. (Exception: subjects receiving warfarin may have an INR between 2 and 3 inclusive). 12. Fertile subjects (and their partners) must agree to use highly effective contraceptive methods (e.g., condoms, oral or injectable contraceptives) during the treatment period and for 6 months after the last dose of the study drug. Exclusion Criteria: 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. 2. Received any other unapproved investigational drug within 4 weeks prior to dosing. 3. 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. 4. Known or suspected allergy to the study drug or its analogue components. 5. Inability to undergo contrast-enhanced MRI scans (e.g., due to pacemakers, contrast agent allergy). 6. Presence of active or uncontrolled infections requiring systemic intravenous treatment, or unexplained fever \>38.5°C during the screening period or before dosing. 7. 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. 8. 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). 9. Uncontrolled hypertension as judged by the investigator (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg despite standard treatment). 10. History of severe cardiovascular disease, such as ventricular arrhythmias requiring clinical intervention; QTc interval \> 480 ms; acute coronary syndrome, congestive heart failure, stroke, or other ≥ Grade III cardiovascular events within 6 months prior to dosing; NYHA class II-IV or LVEF \< 50%. 11. History of other uncured malignancies within the past 3 years or concurrently, except for curable in situ cancers (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin). 12. Presence of two or more intracranial lesions, extracranial metastases, or tumors located in the infratentorial compartment or basal ganglia. 13. Brain MRI indicating that the enhancing edge of the tumor invades the ventricular wall, or the surgical cavity communicates with the ventricle. 14. Psychiatric disorders or poor compliance. 15. Pregnant or lactating women. 16. The investigator considers the subject unsuitable for participation in this clinical study due to other severe systemic diseases or other reasons.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Glioblastoma (GBM) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Beijing Tiantan Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100070, China
-
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
RECRUITINGBeijing, Beijing Municipality, 100730, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an immunotherapy drug outsmart a returning brain tumor?
- Can a RAGE inhibitor tame brain swelling after tumor surgery?
- Can a new tracer reveal hidden tumors?
- Can a custom vaccine train the immune system to fight brain cancer?
- MRI maps Low-Oxygen tumor zones to sharpen radiation strike
- Can a Custom-Made vaccine train the immune system to fight brain cancer?