OncoMatch/Clinical Trials/NCT06617169
Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors
Is NCT06617169 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies MNPR-101-PCTA-177Lu for solid tumor, adult.
Treatment: MNPR-101-PCTA-177Lu — This is an open-label, uncontrolled, multi-center, phase 1a MNPR-101-PCTA-177Lu dose-escalation study in patients with solid tumor cancers. Patients must have participated in the imaging study MNPR-101-D001 (actively recruiting, diagnostic study of MNPR-101-DFO\*-89Zr). * TITE-BOIN will be used to objectively determine dose increase, no dose change, or dose decrease for each group of two patients. * The treatment period consists of two 12-week cycles. Patients will receive three equal fractions of MNPR-101-PCTA-177Lu with radioactivity ranging from 480-2240 MBq on each of Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (12 weeks after Cycle 1 Day 1). * Patients will be followed for 12 weeks after their last dose of MNPR-101-PCTA-177Lu. * Patients will be imaged at specific timepoints during the study.
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
Prior therapy
Must have received: MNPR-101-D001 study participation
Participated in the MNPR-101-D001 study.
Cannot have received: chemotherapy
Exception: short cycle of palliative radiotherapy allowed
Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-PCTA-177Lu.
Cannot have received: radiotherapy
Exception: short cycle of palliative radiotherapy allowed
Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-PCTA-177Lu.
Cannot have received: immunotherapy
Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-PCTA-177Lu.
Cannot have received: radiopharmaceutical
Exception: other than MNPR-101-DFO*-89Zr
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-PCTA-177Lu other than MNPR-101-DFO*-89Zr.
Cannot have received: investigational agent
Exception: other than MNPR-101-DFO*-89Zr
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-PCTA-177Lu other than MNPR-101-DFO*-89Zr.
Lab requirements
Blood counts
Platelets ≤150×10^9/L. Absolute neutrophil count ≤1.5×10^9/L. Hemoglobin <9g/dL (no red blood cell transfusion in the previous 4 weeks).
Kidney function
eGFR ≤45 mL/min determined using BSA-adjusted CKD-EPI 2021 formula
Liver function
AST/ALT >3xULN (institutional upper limits of normal) OR >5×ULN for patients with liver metastases. Bilirubin >1.5xULN OR >3xULN for patients with known Gilbert's Syndrome.
Have evidence of impaired organ function at Screening and prior to dosing, particularly: Bone marrow: i. Platelets ≤150×10^9/L. ii. Absolute neutrophil count ≤1.5×10^9/L. iii. Hemoglobin <9g/dL (no red blood cell transfusion in the previous 4 weeks). Liver function: i. AST/ALT >3xULN (institutional upper limits of normal) OR >5×ULN for patients with liver metastases. ii. Bilirubin >1.5xULN OR >3xULN for patients with known Gilbert's Syndrome. Renal function: i. 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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