Randomized Study of ONC-392 plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who Progressed on Androgen Receptor (AR) Pathway Inhibition

Brief description of study

A dose-escalation phase (phase I) is added to determine RP2D. In phase I, 3 mg/kg dose were added in the dose escalation phase, including 6 patients to receive study drug at 3 mg/kg and Lu 177 vipivotide and 3 patients to receive Lu 177 vipivotide alone. Optional intermediate doses of 6 mg/kg and 1 mg/kg was proposed in case either 3 mg/kg or 10 mg/kg was found to have excess toxicity. DLT observation period updated to 28 days. Added Exploratory Objectives. Trial design has been updated to include dose escalation phase (phase I) and dose expansion phase (phase II).


Clinical Study Identifier: s23-01174
ClinicalTrials.gov Identifier: NCT05682443
Principal Investigator: David R. Wise.
Other Investigators: Fabio Ponzo, Kent P Friedman, Doris Leithner, Minas Platon Economides, Victor Ricardo Adorno Febles, Scot Niglio, Mona P. Natwa, Hank Ng.


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