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Clinical Trial Summary

This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion.


Clinical Trial Description

This Phase 1, open-label, first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetic profile of CTX-8371 monotherapy. Preliminary anti-tumor activity of CTX-8371 will also be assessed. The study will be conducted in 2 cohorts: Dose escalation and Dose expansion. The Dose Escalation Cohort will utilize a 3+3 design to evaluate five dose levels (0.1-10 mg/kg) of CTX-8371 given as an IV infusion once every 2 weeks. Patients in the Dose Expansion Cohort will receive CTX-8371 as an IV infusion at a dose(s) based on data from the Dose Escalation Cohort. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06150664
Study type Interventional
Source Compass Therapeutics
Contact Natalie Warholic
Phone 617-500-8099
Email CTX-8371-001@compasstherapeutics.com
Status Recruiting
Phase Phase 1
Start date March 19, 2024
Completion date April 2026

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