Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors

Open Label Pilot Study Evaluating Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors

The goal of this study is to test a new PET imaging agent in patients with solid tumors. This tracer is made of a radioactively-labeled monoclonal antibody MNPR-101, and can show where tumors are present in the body using a PET-scan. The investigators will investigate if the new imaging agent correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain therapies.

Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 30 minutes. The PET-scans are on separate days within 10 days after injection of the tracer (e.g., 2 hours after injection plus 3-5 days and 7-10 days after injection). Furthermore, the investigators will take blood samples 6 times (5 mL each). Blood pharmacokinetics (PK) will be measured on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10.

The amount of radioactivity injected will range between 37-74 MBq (±10%).

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Colorectal Cancer; Pancreatic Cancer; Ovarian Cancer; Lung Cancer; Bladder Cancer; Urothelial Carcinoma; Triple-negative Breast Cancer; Solid Tumor, Adult
• Intervention / Treatment: Drug: Diagnostic Test: MNPR-101-DFO*-89Zr PET Scan

Detailed Description

This is an open-label pilot study to evaluate MNPR-101-DFO*-89Zr with Positron Emission Tomography/Computed Tomography (PET/CT) imaging in patients with solid tumor cancers: bladder/urothelial, triple-negative breast, lung, colorectal, gastric, ovarian, and pancreatic cancers.

Patients will be recruited from a single center with state-of-the-art PET/CT imaging equipment.

The study involves a single administration of MNPR-101-DFO*-89Zr to all participating patients. Imaging will be performed 2 hours after administration and on two additional days - once between days 3-5 and once between days 7-10.

The final study visit will occur 30 days after dosing.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Director Clinical Operations; Phone Number: 847-724-2466; Email: monitoring@monopartx.com

Study Locations

• Australia
  • Victoria
    • North Melbourne, Victoria, Australia, 3051
      • Recruiting
      • Melbourne Theranostic Innovation Centre (MTIC)
      • Contact: Referral Coordinator; Phone Number: 03 9454 5800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically and/or cytologically confirmed solid tumor cancer
2. Age ≥18 years
3. Measurable disease ≥ 1 cm on prior 18F-FDG PET/CT scan
4. Ability to understand and willingness to sign a written informed consent document
5. A prior standard of care 18F-FDG PET/CT scan within past 60 days
6. Tumor sample available for IHC testing to demonstrate uPAR expression.
7. Females of childbearing potential must have a negative serum pregnancy test at time of screening and a negative urine pregnancy test on Day 1 prior to study drug administration if screening is >7 days prior to Day 1. A rapid serum pregnancy test result performed as standard of care will be accepted if available.
8. Both males and females must agree to use highly effective contraceptive precautions if conception is possible during the dosing period and up to 1 month after dosing
9. Female patients who are lactating must agree to discontinue breastfeeding prior to the dose of study drug and must refrain from breastfeeding for 1 month following the last dose of study drug

Exclusion Criteria:

1. Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-DFO-89Zr, or continuing adverse effects (> grade 1, excluding alopecia, anorexia, fatigue, and neuropathy) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0)
2. 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-DFO-89Zr
3. Significantly abnormal laboratory values, particularly: platelets <75K/mcL; ANC <1.0 K/mcL; AST/ALT >2.5 x ULN; Bilirubin >1.5 x ULN (institutional upper limits of normal); and Serum creatinine ≥1.5 mg/dL or estimated creatinine clearance ≤60 mL/min (Cockcroft and Gault)
4. Other serious, non-malignant diseases that may interfere (e.g., renal, hepatic, or hematologic) with the objectives of the study, safety, or compliance, as judged by the investigator
5. Cognitive impairment or contraindications that may compromise the ability to give informed consent or comply with the requirements of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MNPR-101-DFO*-89Zr; Participants receive a single injection of MNPR-101-DFO*-89Zr on Day 1 with injected activity between 37-74 MBq (±10%).	Drug: Diagnostic Test: MNPR-101-DFO*-89Zr PET Scan; a single injection of MNPR-101-DFO*-89Zr on Day 1 with injected activity between 37-74 MBq (±10%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess dosimetry and biodistribution of product	Calculate the biodistribution and radiation dose to major organs for each patient	Day 1 (10 min, 1h, 2h), Days 3-5, and Days 7-10 days post injection
assess tumor Standard Uptake Values (SUV) of product	Assess concentration of product in tumors at each timepoint for each patient	Day 1 (10 min, 1h, 2h), Days 3-5, and Days 7-10 days post injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess pharmacokinetics (PK) levels of product	Assess amount of product in blood and serum based upon radioactivity measurements at each timepoint for each patient	Day 1 (10 min, 1h, 2h), Days 3-5, and Days 7-10 days post injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess tumor uptake to background and tumor uptake to liver ratios of product	Assess concentration of product in liver and skeletal muscle against tumor(s) uptake at each timepoint for each patient	Day 1 (10 min, 1h, 2h), Days 3-5, and Days 7-10 days post injection

Collaborators and Investigators

• Sponsor: Monopar Therapeutics
• Investigators: Principal Investigator: Prof. Rod Hicks, MD, Melbourne Theranostic Innovation Centre (MTIC)

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: MNPR-101-D001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes