[177Lu]Lu-DOTA-EB-RGD2 Therapy in Patients With Recurrent High-grade Glioma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- [177Lu]Lu-DOTA-EB-RGD2
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov