Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MNPR-101-PCTA-177Lu · 1 trial · 9 indications
Dose-limiting toxicities (DLT) are at least possibly related to MNPR-101-PCTA-177Lu and occur within 6 weeks of C1D1. Participants experiencing a DLT will not receive any further doses. Participants will continue study participation through the 12-week post final dose Safety Visit.
The safety profile of MNPR-101-PCTA-177Lu will be determined through assessment of adverse event (AE) type, incidence, severity, time of appearance, and related causes (detected by physical explorations and laboratory tests). Adverse events will be graded and tabulated using NCI CTCAE v5.0.
| Arm | Type | Description |
|---|---|---|
| Level 0 - MNPR-101-PCTA-177Lu 480 MBq | EXPERIMENTAL | - |
| Level 1 - MNPR-101-PCTA-177Lu 960 MBq | EXPERIMENTAL | - |
| Level 2 - MNPR-101-PCTA-177Lu 1440 MBq | EXPERIMENTAL | - |
| Level 3 - MNPR-101-PCTA-177Lu 1920 MBq | EXPERIMENTAL | - |
| Level 4 - MNPR-101-PCTA-177Lu 2240 MBq | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MNPR-101-PCTA-177Lu | DRUG | MNPR-101-PCTA-177Lu administered intravenously over approximately 20 minutes, followed by a normal saline flush. Dosing will occur on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1. |
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 ...
MNPR-101-PCTA-177Lu is an investigational small molecule being developed for the treatment of solid tumors in adults, including bladder cancer, urothelial carcinoma, triple-negative breast cancer, lung cancer, colorectal cancer, gastric cancer, ovarian cancer, and pancreatic cancer. It is currently in Phase 1 clinical development.
MNPR-101-PCTA-177Lu targets uPAR, the urokinase plasminogen activator receptor. This receptor is involved in tumor progression and metastasis, making it a focus for cancer therapy. The drug is designed to deliver a therapeutic payload to uPAR-expressing tumors.
MNPR-101-PCTA-177Lu is being developed by Monopar Therapeutics Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol MNPR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
MNPR-101-PCTA-177Lu is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is a dose-escalation study designed to assess the safety, tolerability, and preliminary activity of the drug.
MNPR-101-PCTA-177Lu is being evaluated in a Phase 1 dose-escalation trial with the identifier NCT06617169. This active, non-recruiting study is enrolling 12 participants in Australia and includes patients with various solid tumors, such as bladder cancer, triple-negative breast cancer, and pancreatic cancer.
MNPR-101-PCTA-177Lu is a specific formulation of the MNPR-101 platform, where the PCTA chelator is linked to the radioactive isotope lutetium-177. This conjugate is designed for targeted radiotherapy. The drug is distinct from other MNPR-101-based agents that may carry different payloads.