Recurrent Glioblastoma (WHO-Grade IV Glioma)Early Phase 1NCT07648823
Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent Glioblastoma
A Early Phase 1 study testing [177Lu]Lu-XT771 in people with Recurrent Glioblastoma (WHO-Grade IV Glioma) and Recurrent Glioblastoma, run by Beijing Tiantan Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent Glioblastoma (WHO-Grade IV Glioma), Recurrent Glioblastoma, Glioblastoma (GBM)
- What is being tested?
- [177Lu]Lu-XT771
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jun 2026to 1 Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Suitable for Ommaya reservoir placement and meets the conditions for drug administration, as judged by the investigator.
- Tumor resection cavity volume between 2.5 and 25 cm^3.
- 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.
- Toxicity from prior anti-tumor treatments (e.g., chemotherapy, radiotherapy, immunotherapy) recovered to ≤ Grade 1 (excluding alopecia).
- 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).
- 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.
Who cannot join
- 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.
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- 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).
- Uncontrolled hypertension as judged by the investigator (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg despite standard treatment).
- 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%.
- 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).
- Presence of two or more intracranial lesions, extracranial metastases, or tumors located in the infratentorial compartment or basal ganglia.
- Brain MRI indicating that the enhancing edge of the tumor invades the ventricular wall, or the surgical cavity communicates with the ventricle.
- Psychiatric disorders or poor compliance.
- Pregnant or lactating women.
- The investigator considers the subject unsuitable for participation in this clinical study due to other severe systemic diseases or other reasons.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Deling Li, M.D. contact
China2 sites, 2 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Li'ao Wang, M.D., +86 15001171671, wangliao17@163.com
Deling Li, M.D., lideling@bjtth.org
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100730
Zhaohui Zhu, M.D., +86 15909835868, 13611093752@163.com
Zhaohui Zhu, M.D.
About this study
Official title: An Investigator-Initiated Trial to Evaluate the Dosimetry, Safety, Tolerability, and Preliminary Efficacy of a Single-Dose [177Lu]Lu-XT771 Injection in Patients With Recurrent Glioblastoma
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.
Read the detailed description
Background and Rationale:
Glioblastoma (GBM) is a highly aggressive brain tumor associated with poor prognosis, particularly upon recurrence. Standard therapeutic options for recurrent GBM are limited, representing an urgent unmet medical need. Carbonic anhydrase IX (CA IX) and XII (CA XII) are transmembrane proteins specifically overexpressed in the hypoxic microenvironment of glioblastoma. They play critical roles in tumor progression and treatment resistance, yet they exhibit scarce expression in normal tissues. This differential expression makes them ideal targets for targeted radioligand therapy.
Investigational Drug: [177Lu]Lu-XT771 is an investigational, first-in-human (FIH) targeted radiopharmaceutical. It is designed to specifically bind to CA IX and CA XII receptors on the tumor cell surface. Upon binding, the Lutetium-177 isotope delivers localized beta radiation directly to the tumor cells, aiming to destroy the tumor while minimizing radiation exposure to surrounding healthy brain tissue. Preclinical in vivo models have demonstrated that local administration of [177Lu]Lu-XT771 results in prolonged tumor retention, high cumulative radiation absorbed doses, and significant inhibition of tumor proliferation.
Study Procedures: In this exploratory, early-phase dosimetric study, eligible patients with recurrence of glioblastoma will undergo surgical placement of an Ommaya reservoir. Prior to the therapeutic injection, a leakage test using a [68Ga]Ga-XT771 tracer will be performed to ensure there is no leakage into the subcutaneous or subarachnoid spaces. Once safety is confirmed, a single locoregional dose of 3-5 mCi of [177Lu]Lu-XT771 will be directly injected into the tumor cavity via the Ommaya reservoir. Patients will be isolated post-injection until their systemic radioactivity levels fall below the required safety discharge standards.
Monitoring and Dosimetry Assessments: To precisely evaluate the radiation dosimetry and biodistribution, patients will undergo a series of whole-body planar scintigraphy and head/abdomen SPECT/CT scans at multiple pre-defined time points post-injection (e.g., 30 minutes, 2 hours, 24 hours, 48 hours, 72 hours, and 5-7 days). These scans will quantify the drug's distribution and the radiation dose absorbed by both the tumor lesions and normal organs (such as the kidneys).
Patients will be continuously monitored for safety and adverse events. Efficacy will be assessed preliminarily using contrast-enhanced head MRI based on RANO 2.0 criteria. The dosimetry, safety, and pharmacokinetic data gathered from this trial will be crucial for calculating and determining the recommended safe starting dose for a subsequent, larger-scale Phase I clinical trial.
- Conditions
- Recurrent Glioblastoma (WHO-Grade IV Glioma), Recurrent Glioblastoma, Glioblastoma (GBM), Recurrent Glioblastoma IDH Wildtype
- Being tested
- [177Lu]Lu-XT771
- Keywords
- Recurrent Glioblastoma, [177Lu]Lu-XT771, Carbonic Anhydrase IX, Carbonic Anhydrase XII, Safety and Tolerability, Dosimetry, Efficacy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-XT771Drug
[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 group | Role | What they receive |
|---|---|---|
| [177Lu]Lu-XT771 | Experimental | 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. Receives: Drug: [177Lu]Lu-XT771 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Dosimetry
To evaluate the radiation dosimetry and biodistribution of a single locoregional injection of [177Lu]Lu-XT771. It will be quantified using serial whole-body planar scintigraphy and SPECT/CT imaging to measure drug distribution and calculate the cumulative radiation absorbed dose in the tumor cavity and critical normal organs (e.g., kidneys). These dosimetric data will be used to determine the recommended starting dose for future Phase I trials.
Measured: 30 minutes, 2 hours, 24 hours, 48 hours, 72 hours, and 5-7 days post-injection
Incidence and severity of adverse events and incidence of serious adverse events
Safety and tolerability will be evaluated by monitoring the incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs). All AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Assessments include patient complaints, vital signs, physical examinations, 12-lead ECGs, and clinical laboratory abnormalities.
Measured: From the time of informed consent up to 30 days after the last dose
Secondary outcomes (1)
Progression-Free Survival (PFS)
PFS is defined as the time from the date of [177Lu]Lu-XT771 administration until the first date of objectively documented radiographic disease progression or death from any cause. Tumor response and progression will be assessed using contrast-enhanced head MRI based on the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
Measured: Every 8 weeks from the date of injection until disease progression or completion of 1 year of follow-up, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start20 Jun 2026 (estimated)
- Primary completion20 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Glioblastoma (WHO-Grade IV Glioma)Studies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deling Li, Beijing Tiantan Hospital
- Investigators
- Deling Li, M.D., Principal investigator, Beijing Tiantan HospitalZhaohui Zhu, M.D., Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648823
- Sponsor's protocol ID
- HX-A-2026029C
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the early-stage exploratory nature of this early Phase I trial, the small sample size, and confidentiality concerns.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated Trial to Evaluate the Dosimetry, Safety, Tolerability, and Preliminary Efficacy of a Single-Dose [177Lu]Lu-XT771 Injection in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT07648823
- Acronym / sponsor ID
- HX-A-2026029C
- Conditions
- Recurrent Glioblastoma (WHO-Grade IV Glioma), Recurrent Glioblastoma, Glioblastoma (GBM), Recurrent Glioblastoma IDH Wildtype
- Keywords
- Recurrent Glioblastoma, [177Lu]Lu-XT771, Carbonic Anhydrase IX, Carbonic Anhydrase XII, Safety and Tolerability, Dosimetry, Efficacy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:
Glioblastoma (GBM) is a highly aggressive brain tumor associated with poor prognosis, particularly upon recurrence. Standard therapeutic options for recurrent GBM are limited, representing an urgent unmet medical need. Carbonic anhydrase IX (CA IX) and XII (CA XII) are transmembrane proteins specifically overexpressed in the hypoxic microenvironment of glioblastoma. They play critical roles in tumor progression and treatment resistance, yet they exhibit scarce expression in normal tissues. This differential expression makes them ideal targets for targeted radioligand therapy.
Investigational Drug: [177Lu]Lu-XT771 is an investigational, first-in-human (FIH) targeted radiopharmaceutical. It is designed to specifically bind to CA IX and CA XII receptors on the tumor cell surface. Upon binding, the Lutetium-177 isotope delivers localized beta radiation directly to the tumor cells, aiming to destroy the tumor while minimizing radiation exposure to surrounding healthy brain tissue. Preclinical in vivo models have demonstrated that local administration of [177Lu]Lu-XT771 results in prolonged tumor retention, high cumulative radiation absorbed doses, and significant inhibition of tumor proliferation.
Study Procedures: In this exploratory, early-phase dosimetric study, eligible patients with recurrence of glioblastoma will undergo surgical placement of an Ommaya reservoir. Prior to the therapeutic injection, a leakage test using a [68Ga]Ga-XT771 tracer will be performed to ensure there is no leakage into the subcutaneous or subarachnoid spaces. Once safety is confirmed, a single locoregional dose of 3-5 mCi of [177Lu]Lu-XT771 will be directly injected into the tumor cavity via the Ommaya reservoir. Patients will be isolated post-injection until their systemic radioactivity levels fall below the required safety discharge standards.
Monitoring and Dosimetry Assessments: To precisely evaluate the radiation dosimetry and biodistribution, patients will undergo a series of whole-body planar scintigraphy and head/abdomen SPECT/CT scans at multiple pre-defined time points post-injection (e.g., 30 minutes, 2 hours, 24 hours, 48 hours, 72 hours, and 5-7 days). These scans will quantify the drug's distribution and the radiation dose absorbed by both the tumor lesions and normal organs (such as the kidneys).
Patients will be continuously monitored for safety and adverse events. Efficacy will be assessed preliminarily using contrast-enhanced head MRI based on RANO 2.0 criteria. The dosimetry, safety, and pharmacokinetic data gathered from this trial will be crucial for calculating and determining the recommended safe starting dose for a subsequent, larger-scale Phase I clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [177Lu]Lu-XT771 | Experimental | Drug: [177Lu]Lu-XT771All 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [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. | Drug | [177Lu]Lu-XT771 |
Primary outcome
Radiation Dosimetry
Time frame: 30 minutes, 2 hours, 24 hours, 48 hours, 72 hours, and 5-7 days post-injection
To evaluate the radiation dosimetry and biodistribution of a single locoregional injection of [177Lu]Lu-XT771. It will be quantified using serial whole-body planar scintigraphy and SPECT/CT imaging to measure drug distribution and calculate the cumulative radiation absorbed dose in the tumor cavity and critical normal organs (e.g., kidneys). These dosimetric data will be used to determine the recommended starting dose for future Phase I trials.
Incidence and severity of adverse events and incidence of serious adverse events
Time frame: From the time of informed consent up to 30 days after the last dose
Safety and tolerability will be evaluated by monitoring the incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs). All AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Assessments include patient complaints, vital signs, physical examinations, 12-lead ECGs, and clinical laboratory abnormalities.
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: Every 8 weeks from the date of injection until disease progression or completion of 1 year of follow-up, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the early-stage exploratory nature of this early Phase I trial, the small sample size, and confidentiality concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deling Li, M.D. contact
Deling Li, M.D. principal investigator
Beijing Tiantan Hospital
Zhaohui Zhu, M.D. principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [177Lu]Lu-XT771 in people with Recurrent Glioblastoma (WHO-Grade IV Glioma) and Recurrent Glioblastoma, run by Beijing Tiantan Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li'ao Wang, M.D. (+86 15001171671, wangliao17@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Dosimetry (time frame: 30 minutes, 2 hours, 24 hours, 48 hours, 72 hours, and 5-7 days post-injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.