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
1 other identifier
interventional
130
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 nonsmall-cell-lung-cancer
Started Apr 2023
Typical duration for phase_1 nonsmall-cell-lung-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedStudy Start
First participant enrolled
April 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
ExpectedOctober 14, 2025
October 1, 2025
2.7 years
March 14, 2023
October 10, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (7)
Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)
Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years)
Maximum observed concentration of JANX008 (Cmax)
Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years)
Number of participants who develop anti-drug antibodies against JANX008
Up to 4 years
Overall Response Rate
Up to 4 years
Duration of Response
Up to 4 years
- +2 more secondary outcomes
Study Arms (3)
Dose Escalation
EXPERIMENTALSubjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
Backfill Expansion
EXPERIMENTALSubjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
Expansion
EXPERIMENTALSubjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).
Interventions
JANX008 is dosed via IV weekly in a 21-day cycle
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
City of Hope Medical Center
Duarte, California, 91010, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of California San Diego Moores Cancer Center
San Diego, California, 92093, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30308, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Washington University
St Louis, Missouri, 63110, United States
Laura and Isaac Perlmutter Cancer Center NYU Langone Health
New York, New York, 10016, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219, United States
Ohio State University Hospital
Columbus, Ohio, 43210, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janux Therapeutics, MD
Janux Therapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2023
First Posted
March 24, 2023
Study Start
April 19, 2023
Primary Completion
January 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
October 14, 2025
Record last verified: 2025-10