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Trial Title:
Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients with Solid Tumors
NCT ID:
NCT06337084
Condition:
Solid Tumor, Adult
Bladder Cancer
Urothelial Carcinoma
Triple-negative Breast Cancer
Lung Cancer
Colorectal Cancer
Gastric Cancer
Ovarian Cancer
Pancreatic Cancer
Conditions: Official terms:
Triple Negative Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MNPR-101-DFO*-89Zr
Description:
Participants will receive one dose of MNPR-101-DFO*-89Zr infused intravenously on Day 1
for PET scans
Arm group label:
MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging
Intervention type:
Diagnostic Test
Intervention name:
PET/CT Diagnostic Imaging
Description:
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.
Arm group label:
MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Melbourne Theranostic Innovation Centre (MTIC)
Address:
City:
North Melbourne
Zip:
3051
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Referral Coordinator
Phone:
03 9454 5800
Start date:
April 10, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Monopar Therapeutics
Agency class:
Industry
Source:
Monopar Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06337084