An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
University of California, Davis Comprehensive Cancer Center
RECRUITING
Sacramento
University of California San Diego Moores Cancer Center
RECRUITING
San Diego
Georgia
Winship Cancer Institute, Emory University
RECRUITING
Atlanta
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Health System
RECRUITING
Detroit
Missouri
Washington University
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New York
Laura and Isaac Perlmutter Cancer Center NYU Langone Health
RECRUITING
New York
Ohio
The Christ Hospital Cancer Center
RECRUITING
Cincinnati
Ohio State University Hospital
RECRUITING
Columbus
Pennsylvania
University of Pennsylvania, Abramson Cancer Center
RECRUITING
Philadelphia
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
The University of Texas, MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Janux Therapeutics
EGFR-008-001_ct.gov@januxrx.com
858-206-8471
Time Frame
Start Date: 2023-04-19
Estimated Completion Date: 2027-10
Participants
Target number of participants: 130
Treatments
Experimental: Dose Escalation
Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
Experimental: Backfill Expansion
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
Experimental: Expansion
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).
Related Therapeutic Areas
Sponsors
Leads: Janux Therapeutics