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

Last updated: October 10, 2025
Sponsor: Janux Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Carcinoma

Renal Cell Carcinoma

Small Cell Lung Cancer

Treatment

JANX008

Clinical Study ID

NCT05783622
EGFR-008-001
  • Ages 18-100
  • All Genders

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.

Eligibility Criteria

Inclusion

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 clinicalbenefit appropriate for the tumor type

  • Adequate organ function

  • At least 1 measurable lesion per RECIST 1.1

Exclusion

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, orother)

  • On supplemental oxygen

  • Any medical condition or clinical laboratory abnormality likely to interfere withassessment of safety or efficacy of study treatment

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: JANX008
Phase: 1
Study Start date:
April 19, 2023
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • University of California San Diego Moores Cancer Center

    San Diego, California 92093
    United States

    Site Not Available

  • City of Hope Medical Center

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • University of California, Davis Comprehensive Cancer Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • University of California San Diego Moores Cancer Center

    San Diego 5391811, California 5332921 92093
    United States

    Active - Recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Winship Cancer Institute, Emory University

    Atlanta 4180439, Georgia 4197000 30308
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York 14623
    United States

    Site Not Available

  • Laura and Isaac Perlmutter Cancer Center NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Ohio State University Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The Christ Hospital Cancer Center

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • Ohio State University Hospital

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburg, Pennsylvania 15232
    United States

    Site Not Available

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • The University of Texas, MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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