RecruitingPhase 1NCT05783622
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Sponsor
Janux Therapeutics
Enrollment
130 participants
Start Date
Apr 19, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria5
- 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 Criteria7
- 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
Interventions
DRUGJANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Locations(18)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05783622
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