MedTrace Logo

ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC

NCT05682443 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ONC-392 low

ONC-392 will be given as IV infusion, Q4W for up to 13 doses.

DRUG

ONC-392 high

ONC-392 will be given as IV infusion, Q6W for up to 9 doses.

DRUG

lutetium Lu 177 vipivotide tetraxetan

lutetium Lu 177 vipivotide tetraxetan will be given as IV infusion, Q6W, for up to 6 doses.

Sponsors & Collaborators

  • Prostate Cancer Clinical Trials Consortium

    collaborator OTHER

  • OncoC4, Inc.

    lead INDUSTRY

Principal Investigators

  • David Wise, MD · NYU Langone Health

  • Mark Stein, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2026-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05682443 on ClinicalTrials.gov