Active Not RecruitingPhase 1NCT05783622

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

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.

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

StatusActive Not Recruiting
PhasePhase 1
U.S. locations18
SponsorJanux Therapeutics
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.

03
Public criteria

Who may be able to participate

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 appropriate for the tumor type * Adequate organ function * At least 1 measurable lesion per RECIST 1.1 Exclusion 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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