Open Label, Phase 1a, Dose-Escalation Study Evaluating the Safety of Fractionated MNPR-101-PCTA-177Lu Dosing in the Treatment of Solid Tumor Cancers

Trial ID: NCT06617169

Interventional - Phase 1 - Active, not recruiting

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.

Conditions

• Solid Tumor, Adult
• Bladder Cancer
• Urothelial Carcinoma
• Triple-negative Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Gastric Cancer
• Ovarian Cancer
• Pancreatic Cancer

Interventions

• MNPR-101-PCTA-177Lu

Eligibility

Inclusion criteria

• 1. Participated in the MNPR-101-D001 study.
• 2. 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 rapid serum pregnancy test result performed as standard of care will be accepted if available.
• 3. Both males and females must agree to use highly effective contraceptive precautions if conception is possible during the dosing period and up to 3 months after dosing.
• 4. Female patients who are lactating must agree to discontinue breastfeeding prior to the dose of study drug and must refrain from breastfeeding for 3 months following the last dose of study drug.

Exclusion criteria

• 1. Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-PCTA-177Lu.
• 2. Continuing ≥ Grade 3 adverse reactions from prior systemic therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).
• 3. 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.
• 4. 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 Chronic Kidney Disease Epidemiology Collaboration CKD-EPI 2021 formula \[https://www.kidney.org/professionals/kdoqi/gfr\_calculator\].
• 5. Safety event of significance in MNPR-101-D001 study:
• 1. a related CTCAE Grade 4 hematologic or hepatologic event
• 2. a related CTCAE Grade 3 hematologic or hepatologic event which lasted \>30 days
• 6. Unacceptable value for projected organ dose based upon dosimetry from the MNPR-101-D001 study that exceeds safe absorbed dose limits, as determined by Monopar.
• 7. Other serious, non-malignant diseases (e.g., renal, hepatic, or hematologic) that may interfere with objectives of the study, safety, or compliance, as judged by the investigator.
• 8. Cognitive impairment or contraindications that may compromise ability to give informed consent or comply with requirements of the study.

Sponsor

Monopar Therapeutics

Source: ClinicalTrials.gov

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