A Phase 1 interventional study of JANX008 in Non-Small Cell Lung Cancer, Renal Cell Carcinoma and Squamous Cell Carcinoma of the Head and Neck, sponsored by Janux Therapeutics. Active, not recruiting at 18 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Janux Therapeutics · Phase 1, Interventional, and Treatment
This study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 130 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Janux Therapeutics is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
Drug: JANX008
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
Drug: JANX008
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).
Drug: JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Incidence of Dose Limiting Toxicities (DLT)
Time frame: 21 days
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: Up to 4 years
Incidence of Clinically Significant Laboratory Abnormalities
Time frame: Up to 4 years
Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)
Time frame: 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)
Time frame: 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
Time frame: Up to 4 years
Overall Response Rate
Proportion of participants who achieve a complete response or partial response per RECIST v1.1
Time frame: Up to 4 years
Duration of Response
Time from documentation of CR or PR to disease progression per RECIST v1.1
Time frame: Up to 4 years
Progression Free Survival
Time from treatment initiation to disease progression per RECIST v1.1
Time frame: Up to 4 years
Correlation of EGFR expression level with anti-tumor activity and safety
Time frame: Up to 4 years
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Janux Therapeutics