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

NCT07655869 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-18

No results posted yet for this study

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.

Conditions

  • Recurrent High-Grade Gliomas
  • Recurrent Glioblastoma IDH Wildtype

Interventions

DRUG

[177Lu]Lu-DOTA-EB-RGD2

A long-circulating radiolabeled peptide targeting integrin αvβ3. The radiopharmaceutical consists of an RGD2 peptide conjugated to a DOTA chelator and an albumin-binding (EB) motif, labeled with Lutetium-177 (half-life 6.7 days). It is administered intravenously (20-30 min infusion) or locoregionally via Ommaya reservoir directly into the tumor cavity. The study evaluates safety, tolerability, dosimetry, and preliminary efficacy in recurrent high-grade glioma.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Deling Li, M.D. · Beijing Tiantan Hospital

  • Zhaohui Zhu · Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07655869 on ClinicalTrials.gov