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fb-PMT for Glioblastoma

Phase 1
Recruiting
Led By Nicholas Blondin, MD
Research Sponsored by NanoPharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically proven intracranial glioblastoma, with first or second recurrence
Hypertension must be well controlled (≤ 95th percentile) on stable doses of medication
Must not have
A significant vascular disease (e.g., aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study enrollment
History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for at least 3 months prior to first dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing fb-PMT, a new drug that targets many signals cancer cells use to grow, on patients with recurrent Glioblastoma. The drug can enter the brain and disrupt cancer cell communication, potentially stopping their growth.

Who is the study for?
This trial is for adults with recurrent glioblastoma, a type of brain tumor. Participants must have had prior treatment, be on stable steroids if used, and have good performance status. They should not be pregnant or breastfeeding, have serious heart conditions or bleeding disorders, nor can they take certain medications that affect the heart rhythm.
What is being tested?
The study tests fb-PMT's safety and tolerability to determine the appropriate dose for treating recurrent glioblastoma. It involves daily subcutaneous injections by patients or caregivers who must also maintain a treatment diary.
What are the potential side effects?
Potential side effects of fb-PMT are not detailed in this summary but may include typical drug-related reactions such as injection site discomfort, allergic reactions, systemic side effects affecting organs due to its broad action on cancer cell signaling pathways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain cancer has returned for the first or second time.
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My high blood pressure is under control with stable medication.
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I am mostly able to care for myself but may not be able to do active work.
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I can store medicine in a fridge, give daily shots, and keep a treatment diary.
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I have completed and recovered from standard treatments for glioblastoma, including surgery and radiotherapy.
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My recent tests show my organs and bone marrow are working well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.
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I have been cancer-free and off treatment for any other cancer than non-melanoma skin cancer or cervical carcinoma in-situ for at least 3 months.
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I do not have any serious infections or illnesses right now.
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I have a serious or non-healing wound, ulcer, or bone fracture.
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I am not taking any medications that affect my heart's rhythm.
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I have a history of or risk factors for a specific heart rhythm problem.
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I haven't taken drugs that affect liver transport proteins in the last 14 days or longer.
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I have previously been treated with fb-PMT or similar drugs.
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I had surgery within the last 28 days and the wound has not fully healed.
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My heart condition is not severe.
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I do not have a bleeding disorder or a history of bleeding problems in the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Dose Limiting Toxicities [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Establishment of Recommended Phase 2 Dose

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (fb-PMT)Experimental Treatment1 Intervention
Daily subcutaneous injection of fb-PMT in four escalating cohorts to determine maximum tolerated dose, followed by treatment of up to 10 additional patients at maximum tolerated dose.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Malignant Glioma treatments often target multiple cancer cell signaling pathways to inhibit tumor growth and progression. Agents like temozolomide, a standard chemotherapy drug, work by damaging the DNA of cancer cells, leading to cell death. Newer treatments, such as targeted therapies and investigational drugs like fb-PMT, aim to inhibit various signaling pathways simultaneously, which can be more effective against the heterogeneous nature of glioma cells. Additionally, the ability of these drugs to penetrate the blood-brain barrier is critical, as it ensures that therapeutic concentrations reach the tumor site within the brain. This multi-faceted approach is essential for improving outcomes in Malignant Glioma patients, given the tumor's resistance to conventional therapies and its location within the central nervous system.

Find a Location

Who is running the clinical trial?

NanoPharmaceuticals LLCLead Sponsor
Nicholas Blondin, MDPrincipal InvestigatorYale University
Anthony Omuro, MDPrincipal InvestigatorYale University

Media Library

fb-PMT (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05226494 — Phase 1
Malignant Glioma Research Study Groups: Treatment (fb-PMT)
Malignant Glioma Clinical Trial 2023: fb-PMT Highlights & Side Effects. Trial Name: NCT05226494 — Phase 1
fb-PMT (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05226494 — Phase 1
~10 spots leftby Dec 2025