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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06337084




Registration number
NCT06337084
Ethics application status
Date submitted
22/03/2024
Date registered
29/03/2024
Date last updated
23/09/2024

Titles & IDs
Public title
Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients with Solid Tumors
Scientific title
Open Label Pilot Study Evaluating Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients with Solid Tumors
Secondary ID [1] 0 0
MNPR-101-D001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
Bladder Cancer 0 0
Urothelial Carcinoma 0 0
Triple-negative Breast Cancer 0 0
Lung Cancer 0 0
Colorectal Cancer 0 0
Gastric Cancer 0 0
Ovarian Cancer 0 0
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Diagnostic Test: MNPR-101-DFO*-89Zr PET Scan

Experimental: MNPR-101-DFO*-89Zr - Participants receive a single injection of MNPR-101-DFO\*-89Zr on Day 1 with injected activity between 37-74 MBq (±10%).


Treatment: Drugs: Diagnostic Test: MNPR-101-DFO*-89Zr PET Scan
a single injection of MNPR-101-DFO\*-89Zr on Day 1 with injected activity between 37-74 MBq (±10%).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
assess dosimetry and biodistribution of product
Timepoint [1] 0 0
Day 1 (10 min, 1h, 2h), Days 3-5, and Days 7-10 days post injection
Primary outcome [2] 0 0
assess tumor Standard Uptake Values (SUV) of product
Timepoint [2] 0 0
Day 1 (10 min, 1h, 2h), Days 3-5, and Days 7-10 days post injection
Secondary outcome [1] 0 0
assess pharmacokinetics (PK) levels of product
Timepoint [1] 0 0
Day 1 (10 min, 1h, 2h), Days 3-5, and Days 7-10 days post injection

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Theranostic Innovation Centre (MTIC) - North Melbourne
Recruitment postcode(s) [1] 0 0
3051 - North Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Monopar Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT06337084
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof. Rod Hicks, MD
Address 0 0
Melbourne Theranostic Innovation Centre (MTIC)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Director Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
847-794-8435
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06337084