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

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

Trial Details

NCT ID
NCT06617169
Phase
PHASE1
Sponsor
Monopar Therapeutics
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • MNPR-101-PCTA-177Lu
Locations (sample)
  • North Melbourne, Victoria, Australia|-37.79798,144.94512

Key Eligibility Criteria

  • Participated in the MNPR-101-D001 study.
  • 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…
  • Both males and females must agree to use highly effective contraceptive precautions if conception is possible during the dosing period and up to 3 …
  • Female patients who are lactating must agree to discontinue breastfeeding prior to the dose of study drug and must refrain from breastfeeding for 3…

For full eligibility, visit ClinicalTrials.gov.

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