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Clinical Trials in the USA / NCT05783622
Active, not recruiting Phase 1

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

NCT05783622 · tracked via the Priya Life Science USA tracker
Sponsor
Janux Therapeutics
Phase
Phase 1
Started
2023-04-19
Last updated
2026-06-01

Condition(s) studied

Non-Small Cell Lung CancerRenal Cell CarcinomaSquamous Cell Carcinoma of the Head and NeckColorectal CarcinomaSmall Cell Lung CancerPancreatic Ductal AdenocarcinomaTriple-negative Breast Cancer

Investigational drug(s) / intervention(s)

JANX008

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

Study 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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
City of Hope Medical Center Duarte California
University of California, Davis Comprehensive Cancer Center Sacramento California
University of California San Diego Moores Cancer Center San Diego California
Winship Cancer Institute, Emory University Atlanta Georgia
University of Chicago Medical Center Chicago Illinois
University of Michigan Ann Arbor Michigan
Henry Ford Health System Detroit Michigan
Washington University St Louis Missouri
Laura and Isaac Perlmutter Cancer Center NYU Langone Health New York New York
University of North Carolina at Chapel Hill Chapel Hill North Carolina
The Christ Hospital Cancer Center Cincinnati Ohio
Ohio State University Hospital Columbus Ohio
University of Pennsylvania, Abramson Cancer Center Philadelphia Pennsylvania
UPMC Hillman Cancer Center Pittsburgh Pennsylvania
Rhode Island Hospital Providence Rhode Island
Sarah Cannon Research Institute Nashville Tennessee
University of Texas Southwestern Medical Center Dallas Texas
The University of Texas, MD Anderson Cancer Center Houston Texas

More Janux Therapeutics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05783622 on ClinicalTrials.gov ↗ ← All trials in the USA