Clinical Trial · NCT06980519

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

Overview

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.

Sponsor

Fortis Therapeutics

Contacts

Ebrahim S. Delpassand, M.D. Chairman & Medical Director, Nuclear Medicine (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06980519

Drug / Compound

MNPR-101

Isotope(s):
Target(s):
  • uPAR
Ligand Class: Antibodies
Chelator: DFO

MNPR-101

Isotope(s):
Target(s):
  • uPAR
Ligand Class: Antibodies
Chelator: PCTA

Eligibility

Inclusion

  • 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
  • Participated in the Expanded Access Program (EAP) IST-00Ca study

Exclusion

  • 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
  • Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-PCTA-177Lu
  • 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
  • Continuing ≥ Grade 3 adverse reactions from prior systemic therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0)