Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated October 1, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-11-06; most recent amendment 2025-09-30.
Trial Details
NCT Number NCT06126666
Lead Sponsor ABL Bio, Inc.
Conditions Advanced Solid Tumor
Enrollment 96 participants
Start Date 2023-11-07
Primary Completion 2025-12-30 (estimated)
Study Completion 2027-11-15 (estimated)
Updated on ClinicalTrials.gov 2025-10-01