Expanded Access Program for MNPR-101-PCTA-177Lu in Patients with Solid Tumor Cancer

Sponsor: Monopar Therapeutics

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT06980519

Provider View

This program provides access to an investigational treatment, MNPR-101-PCTA-177Lu, for patients with solid tumors that test positive for a specific marker using a special imaging scan.

Patient Parameters

Program Overview

The goal of this Expanded Access Program is to offer the investigational treatment MNPR-101-PCTA-177Lu to patients with solid tumors that show a positive result for the urokinase plasminogen activator receptor (uPAR) using a PET/CT scan with the imaging agent MNPR-101-DFO*-89Zr. This program aims to evaluate the safety and potential benefits of the treatment over a 12-week period.

Description

In this program, patients with solid tumors that have tested positive for a specific marker using a PET/CT scan will receive the investigational treatment MNPR-101-PCTA-177Lu. The treatment involves one cycle, given in two separate doses, at one of four planned dose levels. All patients will receive active treatment, starting at the lowest dose level. Depending on the side effects experienced by the first two patients, the next two patients may receive a higher, the same, or a lower dose. The safety and potential effects on the tumor will be monitored for 12 weeks after treatment. Additionally, the level of radioactivity in blood samples will be checked for four weeks after the dose. Patient survival will be followed for six months after the last dose.

Eligibility Criteria

Inclusion Criteria

  • Previously participated in the Expanded Access Program IST-00Ca study.
  • Have a confirmed diagnosis of advanced or metastatic solid tumor cancer that does not respond to existing treatments, or for which no standard treatment is available or suitable.
  • Able to understand and willing to sign a consent form to participate.

Exclusion Criteria

  • Have received chemotherapy, radiotherapy (except short-term palliative radiotherapy), or immunotherapy within 14 days before starting the treatment.
  • Have ongoing severe side effects from previous treatments.
  • Have had any radiopharmaceutical or investigational treatments within four weeks or five half-lives (whichever is longer) before starting the treatment, except for MNPR-101-DFO*-89Zr.
  • Have impaired organ function, particularly in the bone marrow, liver, kidneys, or heart, based on specific tests.
  • Have other serious non-cancerous diseases or conditions that could interfere with the study or patient safety, as determined by the study doctor.

Locations

FACILITYZIPCITYSTATE
Excel Diagnostics & Nuclear Oncology Center77042HoustonTexas

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