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
Condition(s) studied
Investigational drug(s) / intervention(s)
ABL503: ABL503 will be administered intravenously (IV) on Day 1 and Day 15 of every 28-day cycle in the dose-escalation part. The dosing interval to be used in the dose-expansion part will be re-evaluated based on the emerging safety and PK data from the dose-escalation part of the study.
Study 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
Primary outcome measure(s)
- Number of Subjects with Dose-Limiting Toxicities (DLT) — From Day 1 until disease progression or Day 28, whichever came first
Number of subjects with Dose-Limiting Toxicity (DLT) - Number of subjects with AE, IrAEs, IRRs, SAEs and abnormalities in Lab — From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months
Number of subjects with Adverse Event, Immune-related Adverse Event, Infusion-related Reactions (IRRs), serious AEs, and abnormalities in lab parameters
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | Recruiting |
| USC | Los Angeles | California | Recruiting |
| UCLA | Santa Monica | California | Recruiting |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | Recruiting |
| NEXT Oncology | San Antonio | Texas | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Severance Hospital | Seoul | South Korea | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
More ABL Bio, Inc. trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04762641 on ClinicalTrials.gov ↗ ← All trials in South Korea