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A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors
Sponsor: ABL Bio, Inc.
Summary
This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation study of ABL103 to evaluate the safety, tolerability, MTD (maximum tolerated dose) and/or RP2D (recommended phase 2 dose), pharmacokinetics, immunogenicity, preliminary antitumor activity of ABL103 in subjects with any progressive locally advanced(unresectable) or metastatic solid tumor who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 2 parts: a dose-escalation part and tumor-expansion part
Official title: A Phase 1 Dose Escalation and Expansion Study of ABL103, a Bispecific Antibody of 4-1BB and B7-H4, as a Single Agent in Subjects With Any Progressive Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2023-11-07
Completion Date
2027-11-15
Last Updated
2025-10-01
Healthy Volunteers
No
Conditions
Interventions
ABL103
ABL103 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in tumor-expansion part will be evaluated based on the emerging safety and PK data from the dose-escalation part of the study.
Locations (3)
Seoul National University Bundang Hospital
Seongnam, Seoul, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
Sevrance Hospital
Seoul, South Korea, South Korea