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JANX007

Phase 1

Prostate Cancer | Monoclonal antibody | Oncology |Janux Therapeutics, Inc.|Last Updated: Jan 20, 2026

Target and mechanism

Molecular targetPSMA
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment272

FDA Designations

No designations recorded

Clinical trial landscape

JANX007 · 1 trial · 3 indications

Phase 1 1
NCT05519449Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)Prostate Cancer
RECRUITING272 Analytics
PHASE1RECRUITING
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose Limiting Toxicities (DLT)
3 years
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
3 years

Secondary Endpoints

Area under the concentration time curve to infinity of JANX007 (AUC0-inf)
Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years)
Maximum observed concentration of JANX007 (Cmax)
Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years)
Number of participants who develop anti-drug antibodies against JANX007
Up to 3 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALIV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose.
Backfill ExpansionEXPERIMENTALIV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable.
Monotherapy Expansion Parts A - DEXPERIMENTALIV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D).
Combination ExpansionEXPERIMENTALIV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose

Interventions

NameTypeDescription
JANX007BIOLOGICALJANX007 is dosed via IV in a 21- or 28-day cycle.
DarolutamideDRUGDarolutamide is dosed via oral tablets
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Eligibility Criteria

Age Range18 Years to 100 Years
SexMALE
Healthy VolunteersNo
Study Sites35

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 and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane cont...

Countries:United StatesAustralia
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Competitive Landscape -Prostate Cancer 254 trials

Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT05519449primaryCompletionDate: changed
LOWMay 24, 2026NCT05519449studyFirstPostDate: changed

Frequently asked questions about JANX007

What is JANX007 used for in prostate cancer?

JANX007 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 regulatory authorities.

What does JANX007 target?

JANX007 targets PSMA, or prostate-specific membrane antigen, a protein commonly expressed on prostate cancer cells. By binding to PSMA, the antibody is designed to direct an immune response against PSMA-expressing tumor cells.

Who makes JANX007?

JANX007 is being developed by Janux Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol JANX. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is JANX007 in?

JANX007 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is actively recruiting participants.

What clinical trials is JANX007 in?

JANX007 is being evaluated in a Phase 1 clinical trial with the identifier NCT05519449, titled 'Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)'. The trial is recruiting in the United States and Australia, with an enrollment target of 272 participants.