Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled. The study is open-label, randomized with active control, multi-center study.

Official Title

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

Details

The goal of this clinical trial is to examine the safety and efficacy of ONC-392 in combination with lutetium Lu 177 vipivotide tetraxetan in metastatic castration resistant prostate cancer patient who have disease progressed on androgen receptor pathway inhibition. The main questions it aims to answer are (1) whether it is safe to combine ONC-392 with lutetium Lu 177 vipivotide tetraxetan, (2) whether the combination increases the radiographic progression free survival (rPFS).

In Phase 1 of the trial, participates will be randomized to experimental arm and control arm in 2:1 ratio. In experimental arm, they will be given ONC-392 IV infusion for up to 9 cycles or approximately one year, together with lutetium Lu 177 vipivotide tetraxetan for up to 6 cycles. In Phase 2 of the trial, participants will be randomized to three arms in 1:1:1 ratio. There will be two experimental arms, one with low dose of ONC-392 and one with high dose ONC-392, to be given in IV infusion for up to 9 or 13 cycles or approximately one year, together with lutetium Lu 177 vipivotide tetraxetan for up to 6 cycles. In active control arm for both Phase 1 and Phase 2, participants will be given standard of care treatment with lutetium Lu 177 vipivotide tetraxetan for up to 6 cycles.

Keywords

Metastatic Castration-resistant Prostate Cancer, Prostatic Neoplasms, Immunological Antineoplastic Agents, Antibodies, Immunoglobulins, Monoclonal Antibodies, Immunoglobulin G, 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid, ONC-392 low, ONC-392 high, lutetium Lu 177 vipivotide tetraxetan

Eligibility

Locations

  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • OHSU Knight Cancer Institute accepting new patients
    Portland Oregon 97210 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
OncoC4, Inc.
ID
NCT05682443
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 141 study participants
Last Updated