OncoMatch/Clinical Trials/NCT07648823
Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent Glioblastoma
Is NCT07648823 recruiting? Yes, currently enrolling (Jul 2026). This Early Phase 1 trial studies [177Lu]Lu-XT771 for recurrent glioblastoma (who-grade iv glioma).
Treatment: [177Lu]Lu-XT771 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: CA9 expression (positive)
confirmed CA IX/CA XII positive by histology or [68Ga]Ga-XT771 PET/CT
Required: CA12 expression (positive)
confirmed CA IX/CA XII positive by histology or [68Ga]Ga-XT771 PET/CT
Disease stage
Grade: IV (WHO)
Glioblastoma (WHO-Grade IV Glioma); Recurrent Glioblastoma IDH Wildtype
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Lab requirements
Blood counts
ANC ≥ 1.5 ×10^9/L and WBC ≥ 3 ×10^9 /L (without growth factor support within 28 days prior to dosing); Platelet count ≥ 75 ×10^9/L; Hemoglobin ≥ 90 g/L.
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min.
Liver 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.
Cardiac function
INR ≤ 2.0, APTT ≤ 1.5 × ULN. (Exception: subjects receiving warfarin may have an INR between 2 and 3 inclusive).
Adequate organ and bone marrow function meeting the following criteria: ... (see full text for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07648823 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require CA9?
Yes, CA9 expression is a required biomarker for enrollment.
Does this trial require CA12?
Yes, CA12 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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