MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

Status:

AVAILABLE

MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

Lead Sponsor:

Monopar Therapeutics

Conditions:

Cancer

Solid Tumor

Eligibility:

All Genders

18+ years

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)-positi...

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 frac...

Eligibility Criteria

Inclusion

Key
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

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT06980519

Last Update

May 22 2025

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