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JANX014

Phase 1

Prostate Cancer | Monoclonal antibody | Oncology |Janux Therapeutics, Inc.|Last Updated: Aug 10, 2026

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

Clinical trial landscape

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 Sites4

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 254 trials

Recent Changes (Last 90 Days)

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 developed for the treatment of prostate cancer, specifically metastatic castration-resistant prostate cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

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 stock exchange 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 currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy.

What clinical trials is JANX014 in?

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

Is JANX014 the same as any other drug?

No alternative names for JANX014 have been reported. It is a distinct investigational monoclonal antibody being developed by Janux Therapeutics. Patients and healthcare providers should refer to the drug by its assigned name, JANX014, when discussing the ongoing clinical trial or potential treatment options.