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ACTIVE NOT RECRUITING
NCT05789069
PHASE1

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

Sponsor: HiFiBiO Therapeutics

View on ClinicalTrials.gov

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

DRUG

HFB200603

Participants will be administered HFB200603 as described in the experimental arm.

DRUG

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