What is [177Lu]Lu-DOTA-EB-RGD2 studying for recurrent high-grade glioma?

This trial is studying the safety, dosing limits, and early effects of the drug [177Lu]Lu-DOTA-EB-RGD2 in patients with recurrent high-grade gliomas. Researchers want to find the right dose and understand how the drug behaves in the body. The study is sponsored by Beijing Tiantan Hospital and includes two ways of giving the drug to compare.

Who may be eligible for this recurrent high-grade glioma clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of glioblastoma after surgery or biopsy may be eligible. Participants should have stable or decreasing corticosteroid use at low doses and adequate organ function. They should not have serious heart conditions or active infections. Please review eligibility criteria for more details.

Is there any cost to participate in this recurrent high-grade glioma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Early Phase 1

Age: 18Years +

All Genders

ID07655869

Phase I Study of 177LuLu-DOTA-EB-RGD2 Administered Intravenously or Into Tumor Cavity to Treat Recurrent High-Grade Glioma

Led by Beijing Tiantan Hospital · Updated on 2026-06-18

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new radiopharmaceutical called 177LuLu-DOTA-EB-RGD2 in patients with recurrent high-grade gliomas, including recurrent glioblastoma IDH wildtype. This Phase I clinical trial aims to determine the safety, tolerability, dosimetry, and early anti-tumor effects of this drug. The study uses a dose-escalation design to find the maximum tolerated dose through two different delivery methods intravenous infusion and direct injection into the tumor cavity using an Ommaya reservoir. Participants receive 177LuLu-DOTA-EB-RGD2 either via an intravenous infusion lasting 20 to 30 minutes or through a previously implanted Ommaya reservoir directly into the tumor cavity. Treatments are given every three weeks for up to two cycles, with three dose levels tested per route. Additional treatment cycles may be offered based on the clinical benefit observed. The study is conducted at two Chinese medical centers and includes approximately 24 patients. During the trial, participants undergo regular assessments including MRI scans to monitor tumor response, blood and urine tests for pharmacokinetics and dosimetry, and evaluation of any adverse events. Researchers measure dose-limiting toxicities within six weeks after the first dose and monitor overall survival and objective response rates over up to 17 months. Safety, drug distribution, and effectiveness indicators are closely followed throughout treatment and follow-up periods.

CONDITIONS

Brief Title

[177Lu]Lu-DOTA-EB-RGD2 Therapy in Patients With Recurrent High-grade Glioma

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed informed consent before participation
Age 18 years or older
Histologically confirmed glioblastoma after surgery or biopsy
Stable or decreasing corticosteroid dose 4 mg/day or less for at least 7 days before treatment
Adequate bone marrow and organ function within 14 days before treatment
Evidence of disease progression by RANO 2.0 with measurable lesion at least 10 mm on MRI
Completed Ommaya reservoir implantation surgery at least 2 weeks before treatment (if applicable)
Tumor uptake confirmed by NOTA-PRGD2 PET/CT before treatment
Life expectancy greater than 6 months
Karnofsky Performance Status score of 50 or higher

You will not qualify if you...

Receiving other treatments for glioblastoma outside this study
Pregnant or breastfeeding, or planning pregnancy/breastfeeding during and 6 months after treatment
Refusal to use effective contraception from consent until 6 months after last dose
Unable to tolerate imaging, repeated blood sampling, or poor venous access
Significant cardiac disease or ECG abnormalities posing safety risk
Other malignancies within 5 years except certain treated cancers
Abnormal serum virology or untreated active hepatitis B without therapy
Use of bevacizumab or supportive care within 60 days before treatment
Disease progression within 12 weeks after radiotherapy completion
Prior intracranial locoregional drug therapy before this treatment
Active intracranial or intratumoral hemorrhage
Seizure within 14 days before treatment or uncontrolled epilepsy/increased intracranial pressure
Severe myelosuppression not recovered from prior therapy
Blood transfusion within 4 weeks before screening
Known allergy to study drug components
Severe diseases increasing safety risk
Active infection needing IV antibiotics within 4 weeks before dose
History of drug/alcohol abuse or psychiatric illness affecting compliance
Participation in another investigational trial within 4 weeks before dose

Research Team

Li'ao Wang, M.D.

Deling Li, M.D.

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