Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated February 6, 2025 (before its estimated November 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 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
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-02-17; most recent amendment 2025-02-04.
Status change: Not Yet Recruiting → Recruiting 2021-07-19
Trial Details
NCT Number NCT04762641
Lead Sponsor ABL Bio, Inc.
Conditions Advanced Solid Tumor
Enrollment 100 participants
Start Date 2021-04-01
Primary Completion 2025-11-30 (estimated)
Study Completion 2026-06-15 (estimated)
Updated on ClinicalTrials.gov 2025-02-06