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Tests treatment safety and results for Solid Tumor, Adult
Official title Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT06337084
What this study is testing
What is MNPR-101-DFO*-89Zr?
MNPR-101-DFO*-89Zr is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 people may be enrolled with FDG-avid disease which do not meet ≥ 1 cm measurement on...
- 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.
You likely can't join if
- Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of...
- Prior treatment with any radiopharmaceutical or investigational agents within 4 weeks or 5 effective half-lives, whichever is longer, prior to...
- 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...
- Renal function i. eGFR ≤45 mL/min determined using BSA-adjusted Chronic Kidney Disease Epidemiology Collaboration CKD-EPI 2021 formula...
See the full eligibility criteria
- 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 people 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.
- 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...
- 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.
- 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...
- 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. 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].
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- North Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include North Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.