TrialPath
← Back to searchRecruiting

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

NCT05783622 · Janux Therapeutics
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
About this study
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 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
Study design
Enrollment target: 130 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-04-19
Estimated completion: 2027-10
Last updated: 2025-10-14
Interventions
Drug: JANX008
Primary outcomes
  • Incidence of Dose Limiting Toxicities (DLT) (21 days)
  • Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) (Up to 4 years)
  • Incidence of Clinically Significant Laboratory Abnormalities (Up to 4 years)
Sponsor
Janux Therapeutics · industry
Contacts & investigators
ContactJanux Therapeutics · contact · EGFR-008-001_ct.gov@januxrx.com · 858-206-8471
InvestigatorJanux Therapeutics, MD · study_director, Janux Therapeutics
All locations (18)
City of Hope Medical CenterRecruiting
Duarte, California, United States
University of California, Davis Comprehensive Cancer CenterRecruiting
Sacramento, California, United States
University of California San Diego Moores Cancer CenterRecruiting
San Diego, California, United States
Winship Cancer Institute, Emory UniversityRecruiting
Atlanta, Georgia, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Laura and Isaac Perlmutter Cancer Center NYU Langone HealthRecruiting
New York, New York, United States
University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
The Christ Hospital Cancer CenterRecruiting
Cincinnati, Ohio, United States
Ohio State University HospitalRecruiting
Columbus, Ohio, United States
University of Pennsylvania, Abramson Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Rhode Island HospitalRecruiting
Providence, Rhode Island, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
The University of Texas, MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies · TrialPath