Kidney Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT05783622

Recruitment Status:

Recruiting

Sponsor:

Janux Therapeutics

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There are 7 Locations for this study

See Locations Near You

City of Hope Medical Center
Duarte California, 91010, United States
University of California San Diego Moores Cancer Center
San Diego California, 92093, United States
Washington University
Saint Louis Missouri, 63110, United States
The Christ Hospital Cancer Center
Cincinnati Ohio, 45219, United States
Ohio State University Hospital
Columbus Ohio, 43210, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT05783622

Recruitment Status:

Recruiting

Sponsor:


Janux Therapeutics

How clear is this clinincal trial information?

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