Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
NanoPharmaceuticals LLC
Study ID
NCT05226494
Phase
PHASE1
Status
Recruiting
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Conditions

  • Glioma, Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • fb-PMT — DRUG
    Daily dosing based on patient weight

Study Details

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.

Key Dates

Start date
Jun 23, 2022
Status verified
May 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (fb-PMT)
    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.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 15 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Smilow Cancer HospitalNew HavenConnecticut06511
Nicholas Blondin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Smilow Cancer Hospital· New Haven, CT

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