This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects with Any Progressive Locally Advanced or Metastatic Solid Tumors
Start Date
4/1/2021
Completion Date
6/15/2026
Summary
This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary antitumor activity, and the PD effect of ABL503 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 3 parts: a dose-escalation part, a dose-expansion part and tumor-expansion part
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ABL503
Conditions
Locations
City of Hope
Duarte, California 91010
United States
USC
Los Angeles, California 90033
United States
UCLA
Santa Monica, California 90404
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United States
NEXT Oncology
San Antonio, Texas 78229
United States
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea