[177Lu]Lu-DOTA-EB-RGD2 Therapy in Patients With Recurrent High-grade Glioma (NCT07655869) | Clinical Trial Compass
RecruitingEarly Phase 1
[177Lu]Lu-DOTA-EB-RGD2 Therapy in Patients With Recurrent High-grade Glioma
China24 participantsStarted 2026-06-01
Plain-language summary
This is an investigator-initiated, Phase I clinical trial. It aims to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of a novel radiopharmaceutical, \[177Lu\]Lu-DOTA-EB-RGD2, in patients with recurrent high-grade gliomas. Participants will receive the drug either via intravenous infusion or directly into the tumor cavity through a pre-implanted Ommaya reservoir (a subcutaneously placed device that allows direct access to the tumor cavity). The study employs a "3+3" dose-escalation design to determine the maximum tolerated dose (MTD). Adverse events, biodistribution, and tumor response (by MRI) will be assessed. Approximately 24 patients will be enrolled across two major Chinese medical centers: Beijing Tiantan Hospital and Peking Union Medical College Hospital.
Who can participate
Age range
18 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
. The participant must sign the informed consent form before participation.
. Age ≥ 18 years.
. Histologically confirmed glioblastoma (WHO classification) after surgical resection or biopsy.
. Participants receiving corticosteroids (e.g., dexamethasone) must be on a stable or decreasing dose ≤ 4 mg/day (or equivalent) for at least 7 days before start of study treatment.
. Adequate bone marrow and organ function confirmed by laboratory tests performed ≤ 14 days before first study treatment:
. Evidence of disease progression (PD) by RANO 2.0 criteria confirming recurrence: ≥ 25% increase in product of perpendicular diameters or \> 40% increase in tumor volume compared to baseline after initial treatment or best response, while on stable or increasing corticosteroid dose. Clinical deterioration or increased corticosteroid dose alone is insufficient. MRI contrast enhancement, MRS, and/or metabolic PET should help differentiate true progression from radiation necrosis/pseudoprogression. Also, at least one bi-dimensionally measurable contrast-enhancing lesion with shortest diameter ≥ 10 mm must be present on MRI.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: Within 6 weeks (42 days) after the first dose (during the first two cycles; each cycle is 21 days)
. For participants receiving Ommaya reservoir implantation for locoregional administration, surgery must be completed at least 2 weeks before first radionuclide therapy, with no postoperative complications. Baseline MRI for efficacy assessment must be performed at least 2 weeks after implantation and before first radionuclide therapy.
. Tumor uptake confirmed by NOTA-PRGD2 PET/CT after diagnosis of recurrence and before radionuclide therapy. For participants with Ommaya reservoir, PET/CT must be performed at least 2 weeks after implantation and before first radionuclide therapy.
Exclusion criteria
. Receiving any other concurrent treatment for glioblastoma outside this study.
. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed from the start of \[177Lu\]Lu-DOTA-EB-RGD2 treatment until 6 months after treatment.
. Refusal to use effective contraception during sexual intercourse from informed consent until 6 months after the last dose of study drug.
. Inability to tolerate imaging procedures, repeated blood sampling, or poor venous access.
. Cardiac dysfunction, clinically significant cardiac disease history, or ECG abnormalities indicating a major safety risk, including: