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A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors
Sponsor: HiFiBiO Therapeutics
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2023-05-09
Completion Date
2025-12
Last Updated
2025-11-21
Healthy Volunteers
No
Interventions
HFB200603
Participants will be administered HFB200603 as described in the experimental arm.
Tislelizumab
Participants will be administered tislelizumab as described in the experimental arm.
Locations (11)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
New Experimental Therapeutics of Virginia - NEXT Oncology
Fairfax, Virginia, United States
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona, Italy
Clinica Universidad de Navarra - Madrid
Madrid, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain