Actively Recruiting
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Led by Janux Therapeutics · Updated on 2025-10-14
130
Participants Needed
18
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects 18 years of age or older at the time of signing informed consent
- Diagnosis of locally advanced or metastatic non-small cell lung cancer, squamous cell carcinoma of the head and neck, colorectal carcinoma, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma, or triple-negative breast cancer
- Disease has progressed or patient is intolerant to all available therapies known to benefit their tumor type
- Adequate organ function
- At least one measurable tumor lesion according to RECIST 1.1 criteria
You will not qualify if you...
- Received 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
- Presence of clinically significant cardiovascular diseases
- Active clinically significant infections including bacterial, viral, fungal, or mycobacterial
- Currently on supplemental oxygen
- Any medical condition or abnormal clinical laboratory results that could interfere with safety or efficacy assessment of the study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
3
University of California San Diego Moores Cancer Center
San Diego, California, United States, 92093
Actively Recruiting
4
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
5
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
8
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Laura and Isaac Perlmutter Cancer Center NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
10
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
11
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
12
Ohio State University Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
13
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
15
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
16
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
17
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
18
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Janux Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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