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

Phase 1

Recruiting

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

• Registration Number: NCT06337084
• Lead Sponsor: Monopar Therapeutics

Brief Summary

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%).

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 Timeline

• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-03-29
• Status Verified: 2024-04
• Study Start: 2024-04-10
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging	MNPR-101-DFO*-89Zr	Participants receive a single injection of MNPR-101-DFO\*-89Zr on Day 1 with administered activity between 37-74 MBq (or 1-2 mCi). PET/CT imaging will occur post-infusion at 2 h (Day 1), once on Days 3-5, and once on Days 7-10.
MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging	PET/CT Diagnostic Imaging	Participants receive a single injection of MNPR-101-DFO\*-89Zr on Day 1 with administered activity between 37-74 MBq (or 1-2 mCi). PET/CT imaging will occur post-infusion at 2 h (Day 1), once on Days 3-5, and once on Days 7-10.

Primary Outcome Measures

Name	Time	Method
To assess dosimetry and biodistribution of MNPR-101-DFO*-89Zr	Post infusion at 2 h on Day 1, once on Days 3-5, and once on Days 7-10.	The biodistribution of MNPR-101-DFO\*-89Zr is assessed via PET/CT imaging scans, particularly of target safety organs (e.g., liver, kidney, red marrow, and lungs). Dosimetry is calculated using OLINDA/EXM or a similar software.
To assess tumor Standard Uptake Value (SUV) of MNPR-101-DFO*-89Zr	Post infusion at 2 h on Day 1, once on Days 3-5, and once on Days 7-10.	Tumor SUV is measured via PET/CT imaging by calculating the amount of radiotracer uptake in identified tumors. SUV mean, max, and peak of the tumors will be summarized at each timepoint per subject. Tumor SUV will be analyzed between subjects with the same cancer type as well as between cancer types.
To assess safety of MNPR-101-DFO*-89Zr as assessed by CTCAE 5.0	Screening through Day 30 Safety Visit.	The safety profile of MNPR-101-DFO\*-89Zr will be determined through assessment of adverse event (AE) type, incidence, severity, time of appearance, and related causes (detected by physical explorations and laboratory tests). Adverse events will be graded and tabulated using NCI CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
To assess pharmacokinetics (PK) of MNPR-101-DFO*-89Zr via well or gamma counter	Post infusion at 10 min, 1 h and 2 h on Day 1, once on Days 3-5, and once on Days 7-10.	PK, mean and standard deviation plasma drug concentration are collected and measured via well or gamma counter to assess the imaging agent's interaction in blood and/or serum at each timepoint per subject.

Trial Locations

Locations (1)

Melbourne Theranostic Innovation Centre (MTIC); 🇦🇺 North Melbourne, Victoria, Australia