RecruitingPhase 1NCT05783622

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

Sponsor

Janux Therapeutics

Enrollment

130 participants

Start Date

Apr 19, 2023

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer Colorectal Carcinoma Non-small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma Renal Cell Carcinoma Squamous Cell Carcinoma of the Head and Neck Small Cell Lung Cancer

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called JANX008 in people with advanced or metastatic solid tumors. JANX008 is a bispecific antibody designed to engage the immune system to fight cancer. It is being studied in several types of cancer including non-small cell lung cancer, head and neck cancer, colorectal cancer, kidney cancer, small cell lung cancer, pancreatic cancer, and triple-negative breast cancer. **You may be eligible if:** - You are 18 years old or older - You have one of the listed cancer types (NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, TNBC) confirmed by biopsy, in an advanced or metastatic stage - Your cancer has progressed on or was intolerant to all standard treatments - You have at least one measurable tumor - Your organ function is adequate **You may NOT be eligible if:** - You received cancer treatment within 28 days (or less than 5 drug half-lives) before enrolling - You have previously been treated with an EGFR-targeted bispecific T cell engager - You have significant health conditions that would interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJANX008

JANX008 is dosed via IV weekly in a 21-day cycle

Locations(18)

City of Hope Medical Center

Duarte, California, United States

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States

University of California San Diego Moores Cancer Center

San Diego, California, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Laura and Isaac Perlmutter Cancer Center NYU Langone Health

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

Ohio State University Hospital

Columbus, Ohio, United States

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05783622

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