A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

Active:	Yes
Cancer Type:	Lung Cancer Melanoma	NCT ID:	NCT06150664
Trial Phases:	Phase I	Protocol IDs:	CTX-8371-001 (primary) NCI-2024-04028
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Compass Therapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT06150664

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.

Objectives

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 (0.1-10.0 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 3.0 mg/kg or 10.0 mg/kg at a 1:1 allocation.

Treatment Sites in Georgia

University Cancer and Blood Center, LLC - Athens Medical Oncology
3320 Old Jefferson Road
Building 800
Athens, GA 30607
www.universitycancer.com

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