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

Running, not enrolling · Phase 1

Conditions studied: Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Colorectal Carcinoma, Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Triple-negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT05783622

Run by

Janux Therapeutics

People needed

130

Starts

2023-04-19

Expected to finish

2026-10-31

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope Medical Center — Duarte, California, United States
• University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States
• University of California San Diego Moores Cancer Center — San Diego, California, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Laura and Isaac Perlmutter Cancer Center NYU Langone Health — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• The Christ Hospital Cancer Center — Cincinnati, Ohio, United States
• Ohio State University Hospital — Columbus, Ohio, United States
• University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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