CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 272 target
Drug / intervention
JANX007 +1 morebiological
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Male, age ≥18 years at informed consent
  • ✓Histologically or cytologically confirmed prostate adenocarcinoma
  • ✓Adequate organ function
  • ✓Dose Escalation/Backfill: mCRPC progressed after ≥1 novel anti-androgen and ≥1 taxane (or actively refused/medically unsuitable for taxane)
Key exclusion· 9
  • ✕Prior solid organ transplant
  • ✕Prior PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28, or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
  • ✕Clinically significant cardiovascular disease
  • ✕Monotherapy Part a: Prior treatment other than ARPI or taxane in mCRPC setting

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05519449
NCT05519449Phase 1RecruitingHigh MomentumUpdated 5mo ago
Long Recruiting
CompareCT.gov

A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Janux Therapeutics·interventional·Posted Aug 29, 2022·Updated Jan 20, 2026

In Brief

A Phase 1 clinical trial evaluating JANX007 and Darolutamide for Prostate Cancer and 2 related conditions. Currently recruiting, targeting 272 participants across 35 sites in 2 countries.

Signals

Enrolling ahead of pace

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer
CountriesAustralia, United States
Collaborators--

Timeline

Phase 1Recruiting
2023202420252026202720282029
First PostedAug 29, 2022
Enrollment StartSep 15, 2022
Primary CompletionJul 1, 2027
Study CompletionDec 1, 2028
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 3.8 years agoPrimary completion in 12 months

Interventions

JANX007biological

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

Darolutamidedrug

Darolutamide is dosed via oral tablets