NCT06337084 Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors
| NCT ID | NCT06337084 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Monopar Therapeutics |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-05-30 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-05-30 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open-label pilot study of a new PET/CT imaging agent MNPR-101-DFO\*-89Zr in patients with solid tumor cancers. These cancers may include bladder/urothelial, triple-negative breast, lung, colorectal, gastric, ovarian, and pancreatic cancers. MNPR-101-DFO\*-89Zr is made of MNPR-101, a humanized IgG1 monoclonal antibody and a radioisotope Zirconium-89. This imaging agent may show where tumors are present in the body using a PET-scan. Participants will be injected with the radioactive tracer once. After injection, participants will have 3 PET-scans. Each PET-scan will take about 30 minutes. The PET-scans are on separate days within 10 days after injection (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 study will see if the new imaging agent correctly shows all tumors. In the future, this method may be useful to help predict who will benefit from certain therapies.
Eligibility 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.
Contact & Investigator
Prof. Rod Hicks, MD
PRINCIPAL INVESTIGATOR
Melbourne Theranostic Innovation Centre (MTIC)
Frequently Asked Questions
Who can join the NCT06337084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06337084 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06337084 currently recruiting?
Yes, NCT06337084 is actively recruiting participants. Contact the research team at monitoring@monopartx.com for enrollment information.
Where is the NCT06337084 trial being conducted?
This trial is being conducted at North Melbourne, Australia.
Who is sponsoring the NCT06337084 clinical trial?
NCT06337084 is sponsored by Monopar Therapeutics. The principal investigator is Prof. Rod Hicks, MD at Melbourne Theranostic Innovation Centre (MTIC). The trial plans to enroll 12 participants.