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Active Not RecruitingPhase 1NCT05783622
Official study title

Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedJANX008

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC) · EGFR

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 1, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?Janux Therapeutics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Janux Therapeutics
Interventions being studied
Drug: JANX008
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→Small cell lung cancer (SCLC)→
Disease setting
Metastatic or stage IV→
Biomarkers
EGFR→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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 appropriate for the tumor type
  • Adequate organ function
  • At least 1 measurable lesion per RECIST 1.1
Reasons someone may not be able to joinExclusion criteria
  • Treatment with anti-cancer therapy within 28 days or ≤5 elimination half-lives, whichever is earlier, before enrollment
  • Prior treatment with EGFR-targeted bispecific T cell engager or CAR-T cell therapy
  • Prior treatment with CD3 engaging bispecific antibodies
  • Clinically significant cardiovascular diseases
  • Active clinically significant infection (bacterial, viral, fungal, mycobacteria, or other)
  • On supplemental oxygen
  • Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope Medical CenterDuarte, California
  • University of California, Davis Comprehensive Cancer CenterSacramento, California
  • University of California San Diego Moores Cancer CenterSan Diego, California
  • Winship Cancer Institute, Emory UniversityAtlanta, Georgia
  • University of Chicago Medical CenterChicago, Illinois
  • University of MichiganAnn Arbor, Michigan
  • Henry Ford Health SystemDetroit, Michigan
  • Washington UniversitySt Louis, Missouri
  • Laura and Isaac Perlmutter Cancer Center NYU Langone HealthNew York, New York
  • University of North Carolina at Chapel HillChapel Hill, North Carolina
  • The Christ Hospital Cancer CenterCincinnati, Ohio
  • Ohio State University HospitalColumbus, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 1, 2026. Always confirm current availability with the study team.

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