OncoMatch/Clinical Trials/NCT06337084
Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors
Is NCT06337084 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies MNPR-101-DFO*-89Zr for solid tumor, adult.
Treatment: MNPR-101-DFO*-89Zr — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Urothelial Carcinoma
Triple-Negative Breast Cancer
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Colorectal Cancer
Gastric Cancer
Ovarian Cancer
Pancreatic Cancer
Biomarker criteria
Required: PLAUR overexpression
Tumor sample available for IHC testing to demonstrate uPAR expression.
Prior therapy
Cannot have received: chemotherapy
Exception: short cycle of palliative radiotherapy
Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-DFO*-89Zr
Cannot have received: immunotherapy
Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-DFO*-89Zr
Cannot have received: radiopharmaceutical
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
Cannot have received: investigational agent
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
Lab requirements
Blood counts
Platelets <75 K/mcL; ANC <1.0 K/mcL
Kidney function
eGFR ≤45 mL/min determined using BSA-adjusted CKD-EPI 2021 formula
Liver function
AST/ALT >2.5xULN (or >5xULN for patients with liver metastases); Bilirubin >1.5xULN (or >3xULN for patients with known Gilbert's Syndrome)
Bone marrow: Platelets <75 K/mcL; ANC <1.0 K/mcL. Liver function: AST/ALT >2.5xULN (or >5xULN for patients with liver metastases); Bilirubin >1.5xULN (or >3xULN for patients with known Gilbert's Syndrome). Renal function: eGFR ≤45 mL/min determined using BSA-adjusted CKD-EPI 2021 formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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