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Fb-PMT for Recurrent Glioblastoma

This study is testing a drug called fb-PMT for people with glioblastoma that has come back (recurrent glioblastoma). Glioblastoma is a serious type of brain tumor, and current treatments are limited. Fb-PMT works by affecting many different signals in cancer cells and can cross into the brain. The main goal of this study is to find the safest dose of fb-PMT and see how well people tolerate it. Researchers will be looking at side effects (adverse events) over 15 months and any serious side effects that limit the dose (dose-limiting toxicities) within the first 28 days. You might be able to join if you are 18 or older, have glioblastoma that has returned, and have recovered from previous treatments like surgery and radiation. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 34 participants. The phase of the study is not specified.
What's involved
You would take fb-PMT daily, with the dose based on your weight. You would also need a brain MRI scan within 5 days before starting fb-PMT.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for 15 months and dose-limiting toxicities for 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05226494

Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
NanoPharmaceuticals LLC
~34 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:fb-PMT

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured over 15 months
+1 more outcome measured

Conditions

Glioma, Malignant

Explore related trials

Glioblastoma

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Nicholas Blondin, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically proven intracranial glioblastoma, with first or second recurrence
On stable or decreasing dose of steroids, if taken prior to screening
Baseline MRI (with and without contrast) completed with 5 days of starting fb-PMT
Prior completion of and recovery from the effects of standard of care for glioblastoma management with surgery/biopsy and radiotherapy
Confirmation of true progressive disease for patients previously treated with interstitial brachytherapy or stereotactic radio surgery
Life expectancy of more than three months
Karnofsky Performance Status of ≥ 70
Hypertension must be well controlled (≤ 95th percentile) on stable doses of medication
Adequate bone marrow and organ function, confirmed by laboratory testing at screening
Patient or caregiver must be able to store drug under refrigerated conditions, prepare and administer daily subcutaneous injections on a set schedule, and record information in a daily treatment diary
Women of childbearing potential must agree to ongoing pregnancy testing and to use medically acceptable contraception for the duration of the study and for 2 months after their last dose of study drug
Males must agree to use medically acceptable contraception and refrain from donating sperm for the duration of the study and for 2 months after their last dose of study drug

Exclusion

Significant medical illness that is uncontrolled, may obscure toxicity, may dangerously alter drug metabolism, or may compromise ability for study participation
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
Use of bevacizumab or any other experimental drug or therapy within 28 days of study treatment
Prior therapy with fb-PMT or related drugs
Currently pregnant or breastfeeding
Active infection or serious intercurrent medical illness
Surgery of any type within the preceding 28 days that has not fully healed
A serious or non-healing wound, ulcer, or bone fracture
A known bleeding diathesis or coagulopathy, or a history of bleeding diathesis within 28 days of study treatment
A known thrombophilic condition (i.e., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome). Testing is not required in patients without thrombophilic history.
Evidence of new central nervous system hemorrhage on baseline MRI obtained within 14 days prior to study enrollment
Clinically significant cardiovascular event such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
New York Heart Association classification of heart disease greater than Class 2
QTc interval \> 450 msec in males or \> 470 msec in females at screening
Use of concomitant medications that prolong the QT/QTc interval or risk inducing Torsades de Pointes
Use of any concomitant OATP1B1, OATP1B3, or BSEP inhibitors within 14 days or five half-lives (whichever is longer) before starting study drug treatment
Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment
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 stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months
History of Torsades de Pointes or risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]15 months

    Determined by the number of Treatment-Emergent Adverse Events, including Dose-Limiting Toxicities per patient.

  • Incidence of Dose Limiting Toxicities [Safety and Tolerability]28 Days

    Number of participants with a dose-limiting toxicity during the first cycle (28 days) of treatment at their highest dose level administered.