๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-05

A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (NCT05789069)

A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200603 (Anti-BTLA Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: HiFiBiO Therapeutics

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

The purpose of this study is to test the safety and tolerability of HFB200603 as a single agent and in combination with tislelizumab in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses of HFB200603 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200603 as a single agent or combination therapy is determined. During the expansion part, participants will take the doses of HFB200603 as a monotherapy (optional arm) or in combination with tislelizumab that were determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.

Who can join: Review the eligibility criteria below.

Location: USC Norris Comprehensive Cancer Center โ€” Los Angeles, 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 (11 Sites)

  • USC Norris Comprehensive Cancer Center โ€” Los Angeles, California
  • Fox Chase Cancer Center โ€” Philadelphia, Pennsylvania
  • New Experimental Therapeutics of Virginia - NEXT Oncology โ€” Fairfax, Virginia
  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale โ€” Naples,
  • UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore โ€” Rome,
  • Centro Ricerche Cliniche di Verona s.r.l. โ€” Verona,
  • Clinica Universidad de Navarra - Madrid โ€” Madrid,
  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz โ€” Madrid,
  • South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC โ€” Madrid,
  • Clinica Universidad de Navarra - Pamplona โ€” Pamplona,
  • Hospital Clinico Universitario de Valencia โ€” Valencia,

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. Review the official NIH record below to find the coordinating site.
  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†—