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

a study on Lung Cancer Non-Small Cell Lung Cancer Kidney Cancer Renal Cell Carcinoma Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Colorectal Cancer Pancreatic Ductal Adenocarcinoma Breast Cancer Triple-Negative Breast Cancer Solid Tumor Carcinoma Lung Tumor Colorectal Tumor

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

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, Carcinoma, Lung Neoplasms, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, JANX008, Backfill Expansion, Expansion

Eligibility

You can join if…

Open to people ages 18-100

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • City of Hope Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janux Therapeutics
ID
NCT05783622
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 130 study participants
Last Updated