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Glioma, MalignantPhase 1NCT05226494

Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

A Phase 1 study testing fb-PMT in people with Glioma, Malignant, run by NanoPharmaceuticals LLC at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioma, Malignant
What is being tested?
fb-PMT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
23 Jun 2022to Jun 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Smilow Cancer Hospital

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A Phase 1 Trial to Evaluate the Safety and Tolerability of Fb-PMT in Patients With Recurrent Glioblastoma

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.

Being tested
fb-PMT
Keywords
Glioblastoma, Glioblastoma Multiforme
Medical subject headings
Glioma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fb-PMTDrug

    Also called NP-100, NP751

    Daily dosing based on patient weight

Study groups in NCT05226494
Study groupRoleWhat they receive
Treatment (fb-PMT)ExperimentalDaily 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.
Receives: Drug: fb-PMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

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

    Measured: 15 months

  2. Incidence of Dose Limiting Toxicities [Safety and Tolerability]

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

    Measured: 28 Days

Secondary outcomes (1)

  1. Establishment of Recommended Phase 2 Dose

    Maximum Tolerated Dose, as determined by Dose-Limiting Toxicities.

    Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start23 Jun 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
3+3 Dose Escalation with option for cohort expansion
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05226494
Sponsor's protocol ID
NP-100-101
Status last verified
Aug 2026
First submitted
3 Dec 2021
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing fb-PMT in people with Glioma, Malignant, run by NanoPharmaceuticals LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05226494.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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