Testing JANX008 in patients with advanced solid tumors
An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
PHASE1 · Janux Therapeutics · NCT05783622
This study is testing a new drug called JANX008 to see if it can help adults with advanced solid tumors that keep getting worse, despite other treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Janux Therapeutics (industry) |
| Drugs / interventions | CAR-T |
| Locations | 18 sites (Duarte, California and 17 other locations) |
| Trial ID | NCT05783622 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, Phase 1/1b, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of JANX008 in adult patients with advanced or metastatic solid tumors that express EGFR. The study involves dose escalation and expansion phases to determine the optimal dosing regimen. Eligible participants must have tumors that have progressed despite prior therapies and must have adequate organ function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, colorectal carcinoma, or small cell lung cancer who have not responded to existing therapies.
Not a fit: Patients with significant cardiovascular diseases, active infections, or those who have received certain prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.
How similar studies have performed: Other studies targeting EGFR in advanced solid tumors have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Duarte, California and 17 other locations
- City of Hope Medical Center — Duarte, California, United States (RECRUITING)
- University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States (RECRUITING)
- University of California San Diego Moores Cancer Center — San Diego, California, United States (RECRUITING)
- Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (RECRUITING)
- University of Chicago Medical Center — Chicago, Illinois, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Henry Ford Health System — Detroit, Michigan, United States (RECRUITING)
- Washington University — St Louis, Missouri, United States (RECRUITING)
- Laura and Isaac Perlmutter Cancer Center NYU Langone Health — New York, New York, United States (RECRUITING)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
- The Christ Hospital Cancer Center — Cincinnati, Ohio, United States (RECRUITING)
- Ohio State University Hospital — Columbus, Ohio, United States (RECRUITING)
- University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Rhode Island Hospital — Providence, Rhode Island, United States (RECRUITING)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (RECRUITING)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
- The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Janux Therapeutics
- Email: EGFR-008-001_ct.gov@januxrx.com
- Phone: 858-206-8471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: 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