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RECRUITING
NCT06126666
PHASE1

A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors

Sponsor: ABL Bio, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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