Trials / Recruiting
RecruitingNCT05783622
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Janux Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | JANX008 | JANX008 is dosed via IV weekly in a 21-day cycle |
Timeline
- Start date
- 2023-04-19
- Primary completion
- 2026-01-01
- Completion
- 2027-10-01
- First posted
- 2023-03-24
- Last updated
- 2025-10-14
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05783622. Inclusion in this directory is not an endorsement.