New imaging agent for detecting solid tumors
Open Label Pilot Study Evaluating Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors
This study is testing a new imaging agent to see if it can help find solid tumors in patients better than the usual methods.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Monopar Therapeutics Industry-sponsored |
| Drugs / interventions | Chemotherapy, immunotherapy |
| Locations | 1 site (North Melbourne, Victoria) |
| Trial ID | NCT06337084 on ClinicalTrials.gov |
What this trial studies
This open-label pilot study evaluates the diagnostic efficacy and dosimetry of MNPR-101-DFO*-89Zr, a radiolabeled monoclonal antibody, in patients with various solid tumors. Participants will receive a single infusion of the imaging agent, followed by multiple PET/CT scans over a 10-day period to assess tumor presence and biodistribution. Blood samples will also be collected to analyze pharmacokinetics and safety. The study aims to determine the effectiveness of this new imaging agent compared to standard methods.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed solid tumors that express the urokinase plasminogen activator receptor.
Not a fit: Patients with solid tumors that do not express the urokinase plasminogen activator receptor may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of tumor detection and monitoring in patients with solid tumors.
How similar studies have performed: Other studies using similar radiolabeled monoclonal antibodies for tumor imaging have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Up to 4 subjects may be enrolled with FDG-avid disease which do not meet ≥ 1 cm measurement on CT. 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 effective half-lives, whichever is longer, prior to administration of the first dose of MNPR-101-DFO\*-89Zr. 3. Have evidence of impaired organ function at Screening and within 1 week prior to dosing MNPR-101-DFO\*-89Zr, particularly: * Bone marrow i. Platelets \<75 K/mcL. ii. ANC \<1.0 K/mcL. * Liver function i. AST/ALT \>2.5xULN (institutional upper limits of normal) OR \>5×ULN for patients with liver metastases. ii. Bilirubin \>1.5xULN OR \>3×ULN for patients with known Gilbert's Syndrome. * Renal function i. eGFR ≤45 mL/min determined using BSA-adjusted Chronic Kidney Disease Epidemiology Collaboration CKD-EPI 2021 formula \[https://www.kidney.org/professionals/kdoqi/gfr\_calculator\]. 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.
Where this trial is running
North Melbourne, Victoria
- Melbourne Theranostic Innovation Centre (MTIC) — North Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Prof. Rod Hicks, MD — Melbourne Theranostic Innovation Centre (MTIC)
- Study coordinator: Director Clinical Operations
- Email: monitoring@monopartx.com
- Phone: 847-794-8435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.