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.
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
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There are 8 Locations for this study
Duarte California, 91010, United States
San Diego California, 92093, United States
Chicago Illinois, 60637, United States
Saint Louis Missouri, 63110, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43210, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
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