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

• Status: Not yet recruiting
• Trial end date: 2027-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janux Therapeutics

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