Solid Tumor, AdultPhase 1NCT06337084

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

A Phase 1 study testing MNPR-101-DFO*-89Zr and PET/CT Diagnostic Imaging in people with Solid Tumor, Adult and Bladder Cancer, run by Monopar Therapeutics at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Adult, Bladder Cancer, Urothelial Carcinoma
What is being tested?: MNPR-101-DFO*-89Zr and PET/CT Diagnostic Imaging
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteAustralia
Study dates: 30 May 2024to Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.
Bilirubin >1.5xULN OR >3×ULN for patients with known Gilbert's Syndrome.

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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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Melbourne Theranostic Innovation Centre (MTIC)
North Melbourne, Victoria, 3051

Other trials in Australia

About this study

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

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.

Read the detailed description

This is an open-label, multi-center, imaging, and dosimetry pilot study to evaluate MNPR-101-DFO*-89Zr, a radiolabeled tracer composed of humanized IgG1 monoclonal antibody MNPR-101 which targets cancers that express the urokinase plasminogen activator receptor (uPAR) used with Positron Emission Tomography/Computed Tomography (PET/CT) imaging in patients with solid tumor cancers.

The study aims to determine the dosimetry and biodistribution, tumor standard uptake values (SUV), safety profile, and blood pharmacokinetics (PK) of MNPR-101-DFO*-89Zr.

On Day 1, patients will receive a single infusion of MNPR-101-DFO*-89Zr. All subjects will receive 37 to 74 MBq (1-2 mCi) of 89Zr with radioactivity determined based upon the site's PET/CT equipment. The antibody mass dose of MNPR-101-DFO*-89Zr will be increased in a stepwise fashion to a maximum of 80 mg. Before increasing to the next mass antibody dose level, each cohort of 2 patients will be assessed following the Day 7-10 visit for related hematologic or hepatologic events reported as CTCAE Grade 4, or CTCAE Grade 3 if lasting longer than 30 days.

PET/CT imaging will occur post-infusion at 2 h (Day 1), once on Days 3-5, and once on Days 7-10. PK blood sampling, for analysis via well or gamma counter, will occur post-infusion on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10.

Dosimetry will be calculated using OLINDA/EXM or a similar software. Tumor SUVs will be assessed and compared to a prior 18F-FDG PET scan. PK measurements will be made via well or gamma counter and adjusted for radioactive decay.

The primary endpoints will assess dosimetry, biodistribution including target safety organs (e.g., liver, kidney, bone marrow, and lungs), tumor SUV, and the safety profile of MNPR-101-DFO*-89Zr. Patients will be followed for 1-month post infusion.

Conditions: Solid Tumor, Adult, Bladder Cancer, Urothelial Carcinoma, Triple-negative Breast Cancer, Lung Cancer, Colorectal Cancer
Being tested: MNPR-101-DFO*-89Zr, PET/CT Diagnostic Imaging
Medical subject headings: Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Triple Negative Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MNPR-101-DFO*-89ZrDrug
Participants will receive one dose of MNPR-101-DFO*-89Zr infused intravenously on Day 1 for PET scans
PET/CT Diagnostic ImagingDiagnostic test
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.

Study groups in NCT06337084
Study group	Role	What they receive
MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging	Experimental	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. Receives: Drug: MNPR-101-DFO-89Zr; Diagnostic Test: PET/CT Diagnostic Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Screening through Day 30 Safety Visit.

Secondary outcomes (1)

To assess pharmacokinetics (PK) of MNPR-101-DFO*-89Zr via well or gamma counter
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.
Measured: Post infusion at 10 min, 1 h and 2 h on Day 1, once on Days 3-5, and once on Days 7-10.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 2024Dec 2026

First posted29 Mar 2024
Study start30 May 2024
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06337084
Sponsor's protocol ID: MNPR-101-D001
Status last verified: Sep 2026
First submitted: 22 Mar 2024
Last updated: 3 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
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Advanced or Recurrent Solid Tumors Treated With SHetA2
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NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
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RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
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All Solid Tumor, Adult trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Pilot Study Evaluating Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT06337084
Acronym / sponsor ID: MNPR-101-D001
Conditions: Solid Tumor, Adult, Bladder Cancer, Urothelial Carcinoma, Triple-negative Breast Cancer, Lung Cancer, Colorectal Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 12 participants (estimated)
Lead sponsor: Monopar TherapeuticsIndustry (pharma, biotech, devices)
Study start: 30 May 2024 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 29 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Detailed description

The study aims to determine the dosimetry and biodistribution, tumor standard uptake values (SUV), safety profile, and blood pharmacokinetics (PK) of MNPR-101-DFO*-89Zr.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging	Experimental	Drug: MNPR-101-DFO-89Zr, Diagnostic Test: PET/CT Diagnostic ImagingParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (9 listed)

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:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MNPR-101-DFO-89ZrParticipants will receive one dose of MNPR-101-DFO-89Zr infused intravenously on Day 1 for PET scans	Drug	MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging
PET/CT Diagnostic ImagingPET/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.	Diagnostic test	MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging

Primary outcome

To assess dosimetry and biodistribution of MNPR-101-DFO*-89Zr
Time frame: 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
Time frame: 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
Time frame: 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.

1 secondary outcome

To assess pharmacokinetics (PK) of MNPR-101-DFO*-89Zr via well or gamma counter
Time frame: Post infusion at 10 min, 1 h and 2 h on Day 1, once on Days 3-5, and once on Days 7-10.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Solid Tumor, Adult

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
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RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
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RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
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RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prof. Rod Hicks, MD principal investigator

Melbourne Theranostic Innovation Centre (MTIC)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MNPR-101-DFO*-89Zr and PET/CT Diagnostic Imaging in people with Solid Tumor, Adult and Bladder Cancer, run by Monopar Therapeutics at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess dosimetry and biodistribution of MNPR-101-DFO*-89Zr (time frame: Post infusion at 2 h on Day 1, once on Days 3-5, and once on Days 7-10.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06337084.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.