Dose escalation of MNPR-101-PCTA-177Lu for treating solid tumors
Open Label, Phase 1a, Dose-Escalation Study Evaluating the Safety of Fractionated MNPR-101-PCTA-177Lu Dosing in the Treatment of Solid Tumor Cancers
This study is testing a new treatment called MNPR-101-PCTA-177Lu to see if it can help people with solid tumors like bladder cancer and triple-negative breast cancer feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Monopar Therapeutics Industry-sponsored |
| Drugs / interventions | Chemotherapy, immunotherapy |
| Locations | 1 site (North Melbourne, Victoria) |
| Trial ID | NCT06617169 on ClinicalTrials.gov |
What this trial studies
This open-label, uncontrolled, multi-center Phase 1a study evaluates the safety and efficacy of MNPR-101-PCTA-177Lu in patients with solid tumors, including bladder cancer, urothelial carcinoma, triple-negative breast cancer, and lung cancer. Participants must have previously taken part in the MNPR-101-D001 imaging study. The treatment involves three doses of MNPR-101-PCTA-177Lu administered over two 12-week cycles, with dose adjustments based on a Bayesian Optimal Interval Design. Patients will be monitored for adverse events and undergo imaging to assess treatment response.
Who should consider this trial
Good fit: Ideal candidates are adults with solid tumors who have participated in the MNPR-101-D001 imaging study.
Not a fit: Patients who have received chemotherapy, radiotherapy, or immunotherapy within 14 days prior to the study may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.
How similar studies have performed: While similar approaches have been explored, this specific dose-escalation method using MNPR-101-PCTA-177Lu is novel.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
North Melbourne, Victoria
- Melbourne Theranostic Innovation Centre (MTIC) — North Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Director Clinical Operations
- Email: monitoring@monopartx.com
- Phone: 847-794-8435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.