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New treatment option for Recurrent High-Grade Gliomas
Official title [177Lu]Lu-DOTA-EB-RGD2 Therapy in Patients With Recurrent High-grade Glioma
ClinicalTrials.gov ID: NCT07655869
What this study is testing
What is [177Lu]Lu-DOTA-EB-RGD2?
[177Lu]Lu-DOTA-EB-RGD2 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for recurrent high-grade gliomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Adequate bone marrow and organ function confirmed by laboratory tests performed ≤ 14 days before first study treatment: Absolute neutrophil count...
You likely can't join if
- 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...
- 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: (1) Documented...
See the full eligibility 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: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 10.0...
- 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...
- 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...
- 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...
- Life expectancy \> 6 months.
- Karnofsky Performance Status (KPS) score ≥ 50.
- 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: (1) Documented myocardial infarction, angina pectoris, cardiomyopathy, symptomatic...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.