Trial Title:
Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor Malignancies
NCT ID:
NCT05783622
Condition:
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
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Carcinoma, Renal Cell
Small Cell Lung Carcinoma
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JANX008
Description:
JANX008 is dosed via IV weekly in a 21-day cycle
Arm group label:
Backfill Expansion
Arm group label:
Dose Escalation
Arm group label:
Expansion
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California San Diego Moores Cancer Center
Address:
City:
San Diego
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University
Address:
City:
St. Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14623
Country:
United States
Status:
Recruiting
Facility:
Name:
University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Facility:
Name:
The Christ Hospital Cancer Center
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Facility:
Name:
Ohio State University Hospital
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pennsylvania, Abramson Cancer Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburg
Zip:
15232
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Start date:
April 19, 2023
Completion date:
October 2027
Lead sponsor:
Agency:
Janux Therapeutics
Agency class:
Industry
Source:
Janux Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05783622
