OncoMatch/Clinical Trials/NCT06617169
Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors
Is NCT06617169 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Tumor Agnostic
Urothelial Carcinoma
Triple-Negative Breast Cancer
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
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.
Frequently asked questions
Is NCT06617169 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, radiotherapy, immunotherapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify