A Phase 1 Open-label, Multiple Dose, Dose Escalation Study of Monoclonal Antibody AV-203 Administered in Subjects With Metastatic or Advanced Solid Tumors

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase I
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01603979
Protocol IDs
AV-203-12-101 (primary)
Study Sponsor
AVEO Pharmaceuticals, Incorporated

Summary

This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated in an expansion cohort at the RP2D for safety and anti-tumor activity.

Treatment Sites in Georgia


Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

Study Coordinator:
Akintayo,Adebowale
404-778-5849

Doctors:

Suresh S. Ramalingam MD
Bassel F El-Rayes MD
Bradley C. Carthon, MD, PhD
Taofeek K. Owonikoko MD
William Read , MD