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JANX008

Phase 1

Non-Small Cell Lung Cancer | Small molecule | Oncology |Janux Therapeutics, Inc.|Last Updated: Jun 1, 2026

Target and mechanism

Molecular targetEGFR
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment130

FDA Designations

No designations recorded

Clinical trial landscape

JANX008 · 1 trial · 7 indications

Phase 1 1
NCT05783622Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor MalignanciesNon-Small Cell Lung Cancer
ACTIVE NOT_RECRUITING130 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose Limiting Toxicities (DLT)
21 days
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Up to 4 years
Incidence of Clinically Significant Laboratory Abnormalities
Up to 4 years

Secondary Endpoints

Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)
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 4 years)
Maximum observed concentration of JANX008 (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 4 years)
Number of participants who develop anti-drug antibodies against JANX008
Up to 4 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALSubjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
Backfill ExpansionEXPERIMENTALSubjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
ExpansionEXPERIMENTALSubjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).

Interventions

NameTypeDescription
JANX008DRUGJANX008 is dosed via IV weekly in a 21-day cycle
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Subjects ≥18 years of age at the time of signing informed consent * Histologically or cytologically documented locally advanced or metastatic NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, TNBC * Progressed or was intolerant to all available therapies known to confer clinical benefit app...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 393 trials

Recent Changes (Last 90 Days)

MEDIUMJun 2, 2026NCT05783622Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 2, 2026NCT05783622Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 2, 2026NCT05783622Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT05783622primaryCompletionDate: changed
LOWMay 24, 2026NCT05783622studyFirstPostDate: changed

Frequently asked questions about JANX008

What is JANX008 used for?

JANX008 is an investigational small molecule being developed for Non-Small Cell Lung Cancer. It is also being studied in other advanced or metastatic solid tumor malignancies, including renal cell carcinoma, squamous cell carcinoma of the head and neck, colorectal carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma, and triple-negative breast cancer.

What does JANX008 target?

JANX008 targets EGFR, the epidermal growth factor receptor. By targeting EGFR, the drug is designed to interfere with signaling pathways that can drive tumor growth in certain cancers, including Non-Small Cell Lung Cancer.

Who makes JANX008?

JANX008 is being developed by Janux Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol JANX. The company is conducting clinical research on this investigational drug for oncology indications.

What phase is JANX008 in?

JANX008 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.

What clinical trials is JANX008 in?

JANX008 is being studied in a Phase 1 clinical trial with the identifier NCT05783622, titled "Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies." The trial is active but not recruiting, with an estimated enrollment of 130 participants in the United States.

Is JANX008 the same as any other drug?

No alternative names for JANX008 have been disclosed. The drug is identified by its code name JANX008 in clinical trial registries and by its developer, Janux Therapeutics, Inc.