Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
NCT05783622 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2025-10-14
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.
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
Interventions
- DRUG
-
JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Janux Therapeutics, MD · Janux Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-19
- Primary Completion
- 2026-01-31
- Completion
- 2027-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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