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

Launched by JANUX THERAPEUTICS · Mar 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JANX008 for adults with advanced or metastatic solid tumors, such as certain types of lung cancer, kidney cancer, and breast cancer. The aim is to see how safe the drug is, how well it works, and how the body processes it. This is an early-stage study, meaning it is one of the first tests of this drug in people. The trial is currently recruiting participants who are 18 years or older and have tumors that have not responded to standard treatments. To join, participants must have a measurable tumor and good organ function, among other criteria.

If you or someone you know qualifies for this trial, participants can expect to receive the study drug and undergo regular health evaluations to monitor their safety and any potential side effects. This trial is important because it could help develop new treatment options for patients whose cancer has not responded to existing therapies. It's a chance to contribute to medical research that may benefit others in the future.

Gender

ALL

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, 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