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

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.

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

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Study Details

Study overview

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.

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

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

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Medical Center, Duarte, California, United States, 91010

San Diego

University of California San Diego Moores Cancer Center, San Diego, California, United States, 92093

Chicago

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

St. Louis

Washington University, St. Louis, Missouri, United States, 63110

Buffalo

Roswell Park Cancer Institute, Buffalo, New York, United States, 14623

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Cincinnati

The Christ Hospital Cancer Center, Cincinnati, Ohio, United States, 45219

Columbus

Ohio State University Hospital, Columbus, Ohio, United States, 43210

Philadelphia

University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States, 19104

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janux Therapeutics,

Janux Therapeutics, MD, STUDY_DIRECTOR, Janux Therapeutics

Study Record Dates

2027-10