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
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2024
CompletedFirst Posted
Study publicly available on registry
March 29, 2024
CompletedStudy Start
First participant enrolled
May 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedMay 22, 2025
May 1, 2025
1.8 years
March 22, 2024
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
To assess dosimetry and biodistribution of MNPR-101-DFO*-89Zr
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.
Post infusion at 2 h on Day 1, once on Days 3-5, and once on Days 7-10.
To assess tumor Standard Uptake Value (SUV) of MNPR-101-DFO*-89Zr
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.
Post infusion at 2 h on Day 1, once on Days 3-5, and once on Days 7-10.
To assess safety of MNPR-101-DFO*-89Zr as assessed by CTCAE 5.0
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.
Screening through Day 30 Safety Visit.
Secondary Outcomes (1)
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.
Other Outcomes (2)
To assess tumor uptake to background and tumor uptake to liver ratios
Post infusion at 2 h on Day 1, once on Days 3-5, and once on Days 7-10.
To assess benefit of added cold MNPR-101 antibody
Post infusion at 10 min, 1 h and 2 h on Day 1, once on Days 3-5, and once on Days 7-10.
Study Arms (1)
MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging
EXPERIMENTALParticipants 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.
Interventions
Participants will receive one dose of MNPR-101-DFO\*-89Zr infused intravenously on Day 1 for PET scans
PET/CT imaging will occur post-infusion at 2 h (Day 1), once on Days 3-5, and once on Days 7-10 for tumor lesion observation.
Eligibility Criteria
You may qualify if:
- Histologically and/or cytologically confirmed solid tumor cancer.
- Age ≥18 years.
- 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.
- Ability to understand and willingness to sign a written informed consent document.
- A prior standard-of-care 18F-FDG PET/CT scan within past 60 days.
- Tumor sample available for IHC testing to demonstrate uPAR expression.
- 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.
- 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.
- 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.
You may not qualify if:
- 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).
- 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.
- 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 \[https://www.kidney.org/professionals/kdoqi/gfr\_calculator\].
- 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.
- Cognitive impairment or contraindications that may compromise the ability to give informed consent or comply with the requirements of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Melbourne Theranostic Innovation Centre (MTIC)
North Melbourne, Victoria, 3051, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof. Rod Hicks, MD
Melbourne Theranostic Innovation Centre (MTIC)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2024
First Posted
March 29, 2024
Study Start
May 30, 2024
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share