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Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

NCT05519449 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2026-01-20

No results posted yet for this study

Summary

This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Conditions

Interventions

BIOLOGICAL

JANX007

JANX007 is dosed via IV in a 21- or 28-day cycle.

DRUG

Darolutamide

Darolutamide is dosed via oral tablets

Sponsors & Collaborators

Principal Investigators

  • Janux Therapeutics, MD · Janux Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2027-07-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT05519449 on ClinicalTrials.gov