Search / Trial NCT06617169

Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors

Launched by MONOPAR THERAPEUTICS · Sep 26, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called MNPR-101-PCTA-177Lu for patients with solid tumors, including types of cancer such as bladder, breast, lung, colorectal, gastric, ovarian, and pancreatic cancer. It is a phase 1 study, meaning it is one of the first steps in testing this treatment in humans to see how well it works and to find out the safest dose. To participate, individuals must have previously taken part in a related imaging study. Eligible patients include both men and women aged 65 and older, who are in good health aside from their cancer and are not currently receiving other treatments like chemotherapy or radiation.

During the trial, participants will receive the treatment in three doses over 12 weeks and will be monitored closely with imaging tests to check how their bodies respond. After the final dose, patients will continue to be followed for 12 weeks to assess any effects from the treatment. It's important for participants to adhere to certain guidelines, such as using effective birth control if they are capable of becoming pregnant and not breastfeeding during the study. This trial is actively recruiting participants, and those interested should discuss it with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

  • 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. Patients requiring blood product transfusion within 4 weeks prior to dosing.
  • 5. 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 ≤10g/dL (no red blood cell transfusion in the previous 4 weeks).
  • • • Liver function: i. AST/ALT \>2.5xULN (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 \[https://www.kidney.org/professionals/kdoqi/gfr_calculator\].
  • 6. 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
  • • 7. 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.
  • • 8. 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.
  • • 9. Cognitive impairment or contraindications that may compromise ability to give informed consent or comply with requirements of the study.

About Monopar Therapeutics

Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on advancing innovative therapies for patients with cancer and other serious diseases. Leveraging its proprietary drug development platform, Monopar aims to enhance treatment options by repurposing established compounds and discovering new therapeutics that target unmet medical needs. With a commitment to scientific excellence and patient-centric approaches, Monopar collaborates with academic institutions and industry partners to accelerate the development of its promising pipeline, striving to improve outcomes and quality of life for patients worldwide.

Locations

North Melbourne, Victoria, Australia

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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