๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-02-04

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 (NCT04762641)

A Phase 1 Dose Escalation and Expansion Study of ABL503, a Bispecific Antibody of 4-1BB and PD-L1, As a Single Agent in Subjects with Any Progressive Locally Advanced (unresectable) or Metastatic Solid Tumors

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: ABL Bio, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: City of Hope โ€” Duarte, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (8 Sites)

  • City of Hope โ€” Duarte, California
  • USC โ€” Los Angeles, California
  • UCLA โ€” Santa Monica, California
  • Sarah Cannon Research Institute at HealthONE โ€” Denver, Colorado
  • NEXT Oncology โ€” San Antonio, Texas
  • Seoul National University Hospital โ€” Seoul,
  • Severance Hospital โ€” Seoul,
  • Asan Medical Center โ€” Seoul,

๐Ÿ“ž Contact the Study Coordinator

Phone: +82-31-8014-7039

Email: juyeun.jeon@ablbio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—