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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783622
• Other study ID #: EGFR-008-001
• Status: Recruiting
• Phase: Phase 1
• Start date: April 19, 2023
• Est. completion date: October 2027

Study information

• Verified date: February 2024
• Source: Janux Therapeutics
• Contact: Janux Therapeutics
• Phone: 858-751-4493
• Email: EGFR-008-001_ct.gov[@]januxrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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, or RCC

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Colorectal Carcinoma
• Colorectal Neoplasms
• Non-Small Cell Lung Cancer
• Renal Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	The Christ Hospital Cancer Center	Cincinnati	Ohio
United States	Ohio State University Hospital	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	City of Hope Medical Center	Duarte	California
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Washington University	Saint Louis	Missouri
United States	University of California San Diego Moores Cancer Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Janux Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose Limiting Toxicities (DLT)		21 days
Primary	Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)		Up to 4 years
Primary	Incidence of Clinically Significant Laboratory Abnormalities		Up to 4 years
Secondary	Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)		Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years)
Secondary	Maximum observed concentration of JANX008 (Cmax)		Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years)
Secondary	Number of participants who develop anti-drug antibodies against JANX008		Up to 4 years
Secondary	Overall Response Rate	Proportion of participants who achieve a complete response or partial response per RECIST v1.1	Up to 4 years
Secondary	Duration of Response	Time from documentation of CR or PR to disease progression per RECIST v1.1	Up to 4 years
Secondary	Progression Free Survival	Time from treatment initiation to disease progression per RECIST v1.1	Up to 4 years
Secondary	Correlation of EGFR expression level with anti-tumor activity and safety		Up to 4 years