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JANX014

Phase 1

Prostate Cancer | Monoclonal antibody | Oncology |Janux Therapeutics, Inc.|Trials Updated: Sep 3, 2026

JANX014 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2026

JANX014 target and mechanism

Molecular targetPSMA
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

JANX014 clinical trials

JANX014 · 1 trial · 3 indications

Phase 1 1
NCT07545811Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate CancerProstate Cancer
RECRUITING43 Analytics
PHASE1RECRUITING
Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose Limiting Toxicities (DLTs)
2 years
Incidence of adverse events (AE) and Serious Adverse Events (SAE)
2 years

Secondary Endpoints

Area under the curve from time 0 to t of JANX014 (AUC0-t)
up to 2 years
Maximum observed concentration of JANX014 (Cmax)
up to 2 years
Number of participants who develop anti-drug antibodies against JANX014
up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALJANX014 will be administered at increasing dose levels per cohort to determine the maximum tolerated dose.
Dose ExpansionEXPERIMENTALParticipants will be dosed at levels previously declared tolerable.

Interventions

NameTypeDescription
JANX014BIOLOGICALJANX014 will be administered via IV dosing
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Male ≥18 years of age at the time of signing informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate * For Dose Escalation: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regime...

Countries:United States
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Competitive Landscape -Prostate Cancer 252 trials

Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07545811lastUpdatePostDate: changed
LOWSep 3, 2026NCT07545811lastUpdatePostDate: changed
LOWAug 11, 2026NCT07545811lastUpdatePostDate: changed
LOWAug 11, 2026NCT07545811lastUpdatePostDate: changed
LOWAug 11, 2026NCT07545811lastUpdatePostDate: changed

Frequently asked questions about JANX014

What is JANX014 used for in prostate cancer?

JANX014 is an investigational monoclonal antibody being studied for the treatment of prostate cancer, specifically metastatic castration-resistant prostate cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does JANX014 target?

JANX014 targets PSMA, a protein commonly expressed on prostate cancer cells. By binding to PSMA, the antibody is designed to deliver a therapeutic effect directly to the tumor. This mechanism is being evaluated in an ongoing Phase 1 clinical trial.

Who is developing JANX014?

JANX014 is being developed by Janux Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol JANX. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of JANX014 in patients with metastatic castration-resistant prostate cancer.

What phase is JANX014 in?

JANX014 is in Phase 1 clinical development. It is an investigational drug and has not yet received FDA approval. The ongoing Phase 1 trial is actively recruiting participants with metastatic castration-resistant prostate cancer in the United States.

What clinical trials is JANX014 in?

JANX014 is being studied in a Phase 1 clinical trial with the identifier NCT07545811. This trial, titled 'Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer,' is currently recruiting and aims to enroll 43 male participants aged 18 years and older in the United States.

Is JANX014 the same as any other drug?

No alternative names for JANX014 have been disclosed. It is a distinct investigational monoclonal antibody developed by Janux Therapeutics. As of now, it is only known by its code name JANX014 and is not marketed under any other brand name.