Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05226494

Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

Led by NanoPharmaceuticals LLC · Updated on 2025-06-04

34

Participants Needed

1

Research Sites

275 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Glioblastoma is a highly aggressive and fatal form of primary malignant brain tumor with limited treatment options. fb-PMT affects a large group of cancer cell signaling pathways and thus may be effective in heterogeneous, treatment-resistant tumors such as Glioblastoma. fb-PMT also is actively transported across the blood-brain barrier into the brain. This study is being conducted to determine the dose level for further clinical development of fb-PMT to treat recurrent Glioblastoma.

CONDITIONS

Official Title

Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven intracranial glioblastoma with first or second recurrence
  • Stable or decreasing dose of steroids if taken before screening
  • Baseline MRI with and without contrast completed within 5 days before starting fb-PMT
  • Prior completion and recovery from standard glioblastoma treatments including surgery/biopsy and radiotherapy
  • Confirmation of true progressive disease if previously treated with interstitial brachytherapy or stereotactic radiosurgery
  • Life expectancy greater than three months
  • Karnofsky Performance Status of 70 or higher
  • Well-controlled hypertension on stable medication doses
  • Adequate bone marrow and organ function confirmed by lab tests at screening
  • Ability of patient or caregiver to store drug refrigerated, prepare and administer daily subcutaneous injections, and keep a treatment diary
  • Women of childbearing potential agree to regular pregnancy testing and use medically acceptable contraception during the study and for 2 months after last dose
  • Males agree to use medically acceptable contraception and avoid sperm donation during the study and for 2 months after last dose
Not Eligible

You will not qualify if you...

  • Uncontrolled significant medical illness that may affect drug metabolism or 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 therapy for at least 3 months
  • Use of bevacizumab or any experimental drug within 28 days before study treatment
  • Prior therapy with fb-PMT or related drugs
  • Currently pregnant or breastfeeding
  • Active infection or serious intercurrent medical illness
  • Surgery within the last 28 days that has not fully healed
  • Serious or non-healing wound, ulcer, or bone fracture
  • Known bleeding disorders or recent history of bleeding within 28 days before treatment
  • Known thrombophilic condition or history of one
  • Evidence of new central nervous system hemorrhage on MRI within 14 days before enrollment
  • Significant cardiovascular events such as uncontrolled arrhythmias, heart failure, or heart attack within 6 months
  • New York Heart Association heart disease classification greater than Class 2
  • QTc interval over 450 msec in males or 470 msec in females at screening
  • Use of medications that prolong QT/QTc interval or risk Torsades de Pointes
  • Use of certain drug inhibitors within 14 days or five half-lives before starting treatment
  • Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months before enrollment
  • Significant vascular disease such as aneurysm repair or thrombosis within 6 months
  • History of stroke, heart attack, transient ischemic attack, severe angina, peripheral vascular disease, or moderate to severe heart failure within 6 months
  • History or risk factors for Torsades de Pointes including heart failure, low potassium, or family history of Long QT Syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Smilow Cancer Hospital

New Haven, Connecticut, United States, 06511

Actively Recruiting

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Research Team

A

Amy L Rodrigues, CCRC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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