Overview
The goal of this study is to test a new PET imaging agent in patients with solid tumors. This tracer is made of a radioactively-labeled monoclonal antibody MNPR-101, and can show where tumors are present in the body using a PET-scan. The investigators will investigate if the new imaging agent correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain therapies.
Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 30 minutes. The PET-scans are on separate days within 10 days after injection of the tracer (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 amount of radioactivity injected will range between 37-74 MBq (±10%).
Description
This is an open-label pilot study to evaluate MNPR-101-DFO*-89Zr with Positron Emission Tomography/Computed Tomography (PET/CT) imaging in patients with solid tumor cancers: bladder/urothelial, triple-negative breast, lung, colorectal, gastric, ovarian, and pancreatic cancers.
Patients will be recruited from a single center with state-of-the-art PET/CT imaging equipment.
The study involves a single administration of MNPR-101-DFO*-89Zr to all participating patients. Imaging will be performed 2 hours after administration and on two additional days - once between days 3-5 and once between days 7-10.
The final study visit will occur 30 days after dosing.
Eligibility
Inclusion Criteria:
- Histologically and/or cytologically confirmed solid tumor cancer
- Age ≥18 years
- Measurable disease ≥ 1 cm on prior 18F-FDG PET/CT scan
- 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
Exclusion Criteria:
- 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 half-lives, whichever is longer, prior to administration of the first dose of MNPR-101-DFO-89Zr
- Significantly abnormal laboratory values, particularly: platelets <75K/mcL; ANC <1.0 K/mcL; AST/ALT >2.5 x ULN; Bilirubin >1.5 x ULN (institutional upper limits of normal); and Serum creatinine ≥1.5 mg/dL or estimated creatinine clearance ≤60 mL/min (Cockcroft and Gault)
- 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