NCT05783622Active, not recruitingPhase 1
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 14 Mar 2023
- Start date
- 19 Apr 2023
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Janux Therapeutics
- Diseases
- Triple-negative breast cancer, Head and neck cancer, Kidney cancer, Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT05783622
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 130
- From 19 Apr 2023 to the primary completion date, 31 Jul 2026
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with anti-cancer therapy within 28 days or ≤5 elimination half-lives, whichever is earlier, before enrollment
- Prior treatment with CD3 engaging bispecific antibodies
Other illness
- Clinically significant cardiovascular diseases
- Active clinically significant infection (bacterial, viral, fungal, mycobacteria, or other)
Lab values
- Prior treatment with EGFR-targeted bispecific T cell engager or CAR-T cell therapy
- Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Other
- On supplemental oxygen
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Winship Cancer Institute, Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The Christ Hospital Cancer Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Ohio State University Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Laura and Isaac Perlmutter Cancer Center/ NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania/Abramson Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of California San Diego Moores Cancer Center Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.