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Tests treatment safety and results for Recurrent Glioblastoma (WHO-Grade IV Glioma)
Official title Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT07648823
What this study is testing
What is [177Lu]Lu-XT771?
[177Lu]Lu-XT771 is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for recurrent glioblastoma (who-grade iv glioma).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
You likely can't join if
- Received anti-tumor treatments (including radiotherapy, chemotherapy, biological therapy, endocrine therapy, targeted therapy, etc.) within 4 weeks...
- 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...
- 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...
See the full eligibility 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.
- 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...
- Hepatic function: Total bilirubin ≤ 1.5 × ULN (≤ 2.0 × ULN for people with liver metastases; ≤ 3.0 × ULN for people with confirmed Gilbert's syndrome); ALT and AST ≤ 3 × ULN (\ 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: people receiving warfarin may have an INR between 2 and 3 inclusive).
- Fertile people (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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.