48 Participants Needed

[177Lu]Lu-NeoB for Glioblastoma

Recruiting at 19 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Novartis Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that if you are on corticosteroids like dexamethasone, you must be on a stable dose of 4 mg/day or less for at least 7 days before starting the study treatment. Also, if you are taking medications that affect the heart's QT interval, you may need to stop or replace them with safer alternatives.

What data supports the effectiveness of the treatment [177Lu]Lu-NeoB for glioblastoma?

Research on similar treatments, like [177Lu]Lu-DOTATATE and [177Lu]-DOTA-Octreotate, shows that lutetium-177 can be effective in targeting cancer cells, as it is used in treating neuroendocrine tumors and meningiomas. Additionally, a pilot study on glioblastoma using a different lutetium-177 therapy showed promise in improving tumor control.12345

Is [177Lu]Lu-NeoB safe for use in humans?

There is no specific safety data available for [177Lu]Lu-NeoB, but Lutetium-177 based treatments have been used safely in other conditions, such as prostate cancer and neuroendocrine tumors, with ongoing research to optimize their safety and effectiveness.16789

What makes the drug [177Lu]Lu-NeoB unique for treating glioblastoma?

The drug [177Lu]Lu-NeoB is unique because it uses lutetium-177, a radioactive substance, to target and treat cancer cells, potentially offering a novel approach for glioblastoma treatment by combining imaging and therapy in one agent.1251011

What is the purpose of this trial?

This study will investigate different doses of \[177Lu\]Lu-NeoB in combination with RT and TMZ in participants with newly diagnosed glioblastoma, with methylated or unmethylated promoter, to assess the safety and efficacy of \[177Lu\]Lu-NeoB in combination with the SoC and in recurrent glioblastoma as single agent, to identify the recommended dose and to also explore the safety of the PET imaging agent \[68Ga\]Ga-NeoB and characterize its uptake in the tumor area.

Research Team

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults with newly diagnosed or recurrent glioblastoma. Participants must have stable organ and bone marrow function, a Karnofsky performance status of at least 60%, and be able to give informed consent. They should not have severe liver issues (with specific lab value limits) and if on steroids, they need to be on a low dose for at least a week before the study.

Inclusion Criteria

You must voluntarily agree to participate in the study after being fully informed of all relevant information.
My diagnosis of Glioblastoma was confirmed through surgery or biopsy.
My recent tests show my organs and bone marrow are functioning well.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants with newly diagnosed glioblastoma receive [177Lu]Lu-NeoB in combination with RT and TMZ every 4 weeks for 6 administrations, with up to 4 additional doses if tolerated. Recurrent glioblastoma participants receive [177Lu]Lu-NeoB as a single agent every 3 weeks for 6 administrations, with up to 4 additional doses if tolerated.

24-40 weeks
Weekly safety and efficacy assessments

Follow-up

Participants are monitored for safety, progression of disease, and survival after treatment

Up to 5 years
Regular visits every 8 weeks for MRI assessments

Treatment Details

Interventions

  • [177Lu]Lu-NeoB
  • [68Ga]Ga-NeoB
Trial Overview [177Lu]Lu-NeoB in combination with radiation therapy (RT) and Temozolomide (TMZ) is being tested in new glioblastoma cases, while [177Lu]Lu-NeoB alone is tested in recurrent cases. The study also examines the safety of PET imaging agent [68Ga]Ga-NeoB and its uptake in tumors.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: [177Lu]Lu-NeoB in Combination with Radiotherapy (RT) and Temozolomide (TMZ)Experimental Treatment3 Interventions
In newly diagnosed glioblastoma
Group II: [177Lu]Lu-NeoB as Single AgentExperimental Treatment2 Interventions
In recurrent glioblastoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

The novel radiopharmaceutical agent 177Lu-DOTA-DG was successfully synthesized with a high radiochemical yield and demonstrated excellent stability in human serum for up to 120 hours, indicating its potential for safe use in cancer imaging and therapy.
In preclinical studies, 177Lu-DOTA-DG caused significantly more DNA damage in cancer cells compared to untreated cells, suggesting its efficacy as a targeted treatment for cancer tissues.
In vivo and in vitro evaluation of 177Lu-labeled DOTA-2-deoxy-D-glucose in mice. A novel radiopharmaceutical agent for cells imaging and therapy.Zhang, J., Wang, Z., Liu, H., et al.[2019]
The combination of the p53 stabilizing peptide VIP116 and the radiotherapy agent [177Lu]Lu-DOTATATE significantly improved median survival in mice with neuroblastoma, extending it to over 120 days compared to 90 days for VIP116 and 96.5 days for [177Lu]Lu-DOTATATE alone.
Importantly, none of the treatments caused significant kidney damage, indicating a favorable safety profile, while also enhancing the effectiveness of the therapy by targeting key processes like apoptosis and angiogenesis.
p53 stabilisation potentiates [177Lu]Lu-DOTATATE treatment in neuroblastoma xenografts.Berglund, H., Salomonsson, SL., Mohajershojai, T., et al.[2023]
The study involving 21 patients with recurrent glioblastoma demonstrated that treatment with [225Ac]Ac-DOTA-SP is safe and well tolerated, even at higher doses of 30 MBq, with only mild temporary side effects reported.
The median overall survival time after diagnosis of recurrence was 13.2 months, indicating that while the treatment is well tolerated, the overall survival benefits need further investigation.
Dose escalation study of targeted alpha therapy with [225Ac]Ac-DOTA-substance P in recurrence glioblastoma - safety and efficacy.Królicki, L., Bruchertseifer, F., Kunikowska, J., et al.[2021]

References

In vivo and in vitro evaluation of 177Lu-labeled DOTA-2-deoxy-D-glucose in mice. A novel radiopharmaceutical agent for cells imaging and therapy. [2019]
p53 stabilisation potentiates [177Lu]Lu-DOTATATE treatment in neuroblastoma xenografts. [2023]
Dose escalation study of targeted alpha therapy with [225Ac]Ac-DOTA-substance P in recurrence glioblastoma - safety and efficacy. [2021]
First clinical experience with fractionated intracavitary radioimmunotherapy using [177Lu]Lu-6A10-Fab fragments in patients with glioblastoma: a pilot study. [2023]
In Vivo Measurement and Characterization of a Novel Formulation of [177Lu]-DOTA-Octreotate. [2020]
A review of advances in the last decade on targeted cancer therapy using 177Lu: focusing on 177Lu produced by the direct neutron activation route. [2023]
Biodistribution and dosimetry of a single dose of albumin-binding ligand [177Lu]Lu-PSMA-ALB-56 in patients with mCRPC. [2021]
A phase IIa trial of molecular radiotherapy with 177-lutetium DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma. [2021]
Safety and Therapeutic Optimization of Lutetium-177 Based Radiopharmaceuticals. [2023]
Production logistics of 177Lu for radionuclide therapy. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Short-Interval, Low-Dose [ 177 Lu]Lu-Prostate-Specific Membrane Antigen in the Treatment of Refractory Glioblastoma. [2023]
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