NCT06150664

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

A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Compass Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 (0.1-10.0 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.

Conditions

• Non Small Cell Lung Cancer
• Triple Negative Breast Cancer
• Hodgkin Lymphoma
• Head and Neck Squamous Cell Carcinoma
• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	CTX-8371	Intravenous (IV) infusion every two weeks.

Timeline

• Start date: 2024-03-19
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2023-11-29
• Last updated: 2025-12-12

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study