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

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, RCC, SCLC, PDAC, TNBC
• 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