Actively Recruiting
Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors
Led by Monopar Therapeutics · Updated on 2025-05-21
12
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participated in the MNPR-101-D001 imaging study
- Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 if screening is more than 7 days before dosing
- Both males and females must agree to use highly effective contraception during dosing and for 3 months after dosing
- Female patients who are breastfeeding must stop before dosing and avoid breastfeeding for 3 months after the last dose
You will not qualify if you...
- Chemotherapy, radiotherapy (except short-term palliative), or immunotherapy within 14 days before dosing
- Ongoing Grade 3 or higher adverse reactions from prior systemic therapy
- Prior treatment with radiopharmaceuticals or investigational agents within 4 weeks or 5 half-lives before the first dose, except MNPR-101-DFO*-89Zr
- Impaired organ function at screening including low platelets, low neutrophil count, anemia, elevated liver enzymes or bilirubin, or low kidney function (eGFR <45 mL/min)
- Significant related Grade 4 hematologic or liver events, or Grade 3 events lasting over 30 days in prior imaging study
- Projected organ dose exceeding safe limits from prior dosimetry
- Serious non-malignant diseases affecting safety or compliance
- Cognitive impairment or other issues preventing informed consent or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Melbourne Theranostic Innovation Centre (MTIC)
North Melbourne, Victoria, Australia, 3051
Actively Recruiting
Research Team
D
Director Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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