Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337084
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-22
Brief Title:
Diagnostic Efficacy and Dosimetry of MNPR-101-DFO-89Zr in Patients with Solid Tumors
Sponsor:
Monopar Therapeutics
Organization:
Monopar Therapeutics
Study Overview
Official Title:
Open Label Pilot Study Evaluating Diagnostic Efficacy and Dosimetry of MNPR-101-DFO-89Zr in Patients with Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label pilot study of a new PETCT imaging agent MNPR-101-DFO-89Zr in patients with solid tumor cancers These cancers may include bladderurothelial 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 eg 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
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 eg 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 TomographyComputed Tomography PETCT 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 sites PETCT 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
PETCT 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 OLINDAEXM 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 eg 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
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 sites PETCT 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
PETCT 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 OLINDAEXM 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None