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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 387 trials

Top 20 of 83 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK24PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Pembrolizumab Berahyaluronidase alfa, Intismeran autogene
AstraZeneca PLCAZN62PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Revolution Medicines, Inc.RVMD8PHASE3Daraxonrasib, Elironrasib, Zoldonrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV10PHASE3Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab, Budigalimab, ABBV-927
Bristol-Myers Squibb CompanyBMY18PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant
Pfizer Inc.PFE16PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Johnson & JohnsonJNJ17PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS9PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, trametinib
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN6PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
BeyondSpring Inc.BYSI1PHASE3Plinabulin
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Frequently asked questions about JANX008

What is JANX008 used for?

JANX008 is an investigational small molecule being developed for the treatment of Non-Small Cell Lung Cancer. It is currently in Phase 1 clinical development and is being studied in patients with advanced or metastatic solid tumor malignancies, including Non-Small Cell Lung Cancer.

What does JANX008 target?

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

Who is developing JANX008?

JANX008 is being developed by Janux Therapeutics, Inc., a biopharmaceutical company. Janux Therapeutics is listed on the stock exchange under the ticker symbol JANX.

What phase is JANX008 in?

JANX008 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial is active but not recruiting participants.

What clinical trials is JANX008 in?

JANX008 is being evaluated in a Phase 1 clinical trial with the identifier NCT05783622. This trial is studying JANX008 in subjects with advanced or metastatic solid tumor malignancies, including Non-Small Cell Lung Cancer, and is being conducted in the United States.

Is JANX008 the same as any other drug?

JANX008 is the drug name used in clinical development. No alternative names have been established for this investigational agent. It is being studied under the name JANX008 in clinical trials.