NCT05238883

A Study of HFB200301 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 HFB200301 (TNFR2 Agonist 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: 72 (actual)
• 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 HFB200301 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 HFB200301 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200301 as a single agent or combination therapy is determined. During the expansion part, participants will take the dose of HFB200301 as a monotherapy or in combination with tislelizumab that was 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/1b, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of 1. A Screening Period 2. A Treatment Period during which participants will receive the study drug on the first day of each cycle 3. A Follow-up Period

Conditions

• Gastric Cancer
• Renal Cell Carcinoma
• Melanoma
• Sarcoma
• Testicular Germ Cell Tumor
• Cervical Cancer
• Mesothelioma
• Non Small Cell Lung Cancer
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	HFB200301	Participants will be administered HFB200301 as described in the experimental arm.
DRUG	Tislelizumab	Participants will be administered tislelizumab as described in the experimental arm.

Timeline

• Start date: 2022-03-10
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-02-14
• Last updated: 2025-11-21

Locations

10 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study