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JANX013

Phase 1

Prostate Cancer | Small molecule | Oncology |Janux Therapeutics, Inc.|Last Updated: Sep 10, 2026

Target and mechanism

Molecular targetPSMA
Target classAntigen
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

JANX013 · 1 trial · 4 indications

Phase 1 1
NCT07813637Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPCProstate Cancer
NOT YET_RECRUITING110 Analytics
PHASE1NOT YET_RECRUITING
Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
2 years
Incidence of cytokine release syndrome (CRS)
2 years

Cytokine release syndrome (CRS) assessed according to ASTCT criteria.

Secondary Endpoints

Area under the curve from 0 to t of JANX013 and JANX007
Up to 2 years
Maximum observed concentration of JANX013 and JANX007
Up to 2 years
Time to maximum concentration of JANX013 and JANX007
Up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALParticipants receive JANX013 in combination with JANX007 administered at increasing dose levels per cohort
Dose ExpansionEXPERIMENTALParticipants receive JANX013 in combination with JANX007. Participants will be dosed at levels previously declared tolerable.

Interventions

NameTypeDescription
JANX013DRUGJANX013 will be administered via IV dosing.
JANX007DRUGJANX007 will be administered via IV dosing.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo

Key Inclusion Criteria: * Male participants ≥ 18 years of age at the time of signing informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate For Dose Escalation: \- Have received at least 1 novel ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, or da...

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Competitive Landscape -Prostate Cancer 252 trials

Recent Changes (Last 90 Days)

LOWSep 10, 2026NCT07813637NEW_TRIAL: changed
LOWSep 10, 2026NCT07813637NEW_TRIAL: changed