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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.

Phase 1RecruitingMonopar TherapeuticsNCT06337084Data as of May 2026

Treatment: MNPR-101-DFO*-89ZrThis 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.

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Extracted 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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