RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor Malignancies

Quick Facts

Study Start:2023-04-19

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05783622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Janux Therapeutics

CONTACT

858-751-4493

EGFR-008-001_ct.gov@januxrx.com

Principal Investigator

Janux Therapeutics, MD

STUDY_DIRECTOR

Janux Therapeutics

Study Locations (Sites)

City of Hope Medical Center

Duarte, California, 91010

United States

University of California San Diego Moores Cancer Center

San Diego, California, 92093

United States

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Washington University

St. Louis, Missouri, 63110

United States

Roswell Park Cancer Institute

Buffalo, New York, 14623

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

Pittsburg, Pennsylvania, 15232

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: Janux Therapeutics

Janux Therapeutics, MD, STUDY_DIRECTOR, Janux Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-19

Study Completion Date2027-10

Study Record Updates

Study Start Date2023-04-19

Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

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