NCT05789069

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: HiFiBiO Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1a/b, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of 1. A Screening Period of up to 28 days 2. A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 21 days. Number of cycles depends on how the disease responds to the study drug 3. A Follow-up Period which involves 2 visits

Conditions

• Renal Cell Carcinoma
• Melanoma
• Non Small Cell Lung Cancer
• Gastric Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-09
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-03-29
• Last updated: 2025-11-21

Locations

11 sites across 3 countries: United States, Italy, Spain

Regulatory

• FDA-regulated drug study