Clinical trial NCT06980519: MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer
Official title: Treatment of Patients With Solid Tumor Cancers Via Intermediate-Size Patient Population Expanded Access Investigational New Drug (IND)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Cancer
Solid Tumor
Solid Tumor Cancer
Oncology
uPAR-positive Solid Tumor
Urokinase Plasminogen Activator Receptor-positive Solid Tumor
Keywords: MNPR-101-PCTA-177Lu
SPECT
SPECT/CT
CT
Radiotherapy
Radiologic response
Single Photon Emission Computed Tomography
Computed Tomography
Monoclonal antibody radionuclide conjugate
Antibody radionuclide conjugate
Lutetium-177
Single Photon Emission Computed Tomography/Computed Tomography
Urokinase plasminogen activator receptor-positive
uPAR-positive
Positron emission tomography/computed tomography
PET/CT
EAP IST-00Ca
Lead sponsor: Monopar Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-05-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this Expanded Access Program (EAP) is to allow use of the investigational therapeutic agent, MNPR-101-PCTA-177Lu, for treatment of urokinase plasminogen activator receptor (uPAR)-positive solid tumors identified via positron emission tomography / computed tomography (PET/CT) with investigational imaging agent MNPR-101-DFO\*-89Zr.

Detailed description: This EAP will enroll patients with uPAR-positive solid tumor cancer confirmed by prior PET/CT imaging with MNPR-101-DFO\*-89Zr (EAP IST-00Ca). Eligible patients will be treated with 1 cycle (as 2 fractionated doses) of investigational therapy, MNPR-101-PCTA-177Lu, at 1 of 4 planned dose levels. All enrolled patients will receive active treatment. Dosing of patients will begin at the lowest planned dose level. After 2 patients are dosed at a level, the next 2 patients may receive the next higher dose level, the same dose level, or a lower dose level, based upon the nature and severity of adverse reactions (side effects). The safety, tolerability, and potential antitumor effects (radiologic response) of MNPR-101-PCTA-177Lu will be evaluated over 12 weeks after dosing. The amount of radioactivity in blood samples will be checked over 4 weeks post dose. Patient survival will be followed up 6 months after the last dose received.

Eligibility criteria: Key Inclusion Criteria:

* Participated in the Expanded Access Program (EAP) IST-00Ca study
* Histologically or cytologically confirmed locally advanced or metastatic solid tumor cancer that is refractory to existing therapy(ies) known to provide clinical benefit, or for which no standard treatment is available, or is contraindicated
* Ability to understand and willingness to sign a written informed consent document

Key Exclusion Criteria:

* Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-PCTA-177Lu
* Continuing ≥ Grade 3 adverse reactions from prior systemic therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0)
* Prior treatment with any radiopharmaceutical or investigational agents within 4 weeks or 5 half-lives, whichever is longer, prior to administration of the first dose of MNPR-101-PCTA-177Lu other than MNPR-101-DFO\*-89Zr
* Evidence of impaired organ function, particularly bone marrow, liver, kidney, or heart, according to specific test parameters
* Presence of other serious, non-malignant diseases or any other condition that, in the opinion of the investigator, could interfere with the objectives of the study, participant safety, or compliance

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Excel Diagnostics & Nuclear Oncology Center
state: Texas
Study officials:
affiliation: Excel Diagnostics & Nuclear Oncology Center
name: Ebrahim S. Delpassand, M.D. Chairman & Medical Director, Nuclear Medicine
role: PRINCIPAL_INVESTIGATOR
References: