A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

Summary

The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable doses of HFB301001 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer they have.

Timeline

Start

2022-04-20

Primary completion

2024-05-30

Completion

2024-05-30

Outcome

Outcome not reported

Stopped (Enrollment): “The decision to discontinue the trial was made as part of a strategic review of the Sponsor's global development portfolio. It is not related to any safety concerns, efficacy findings, recruitment difficulties, or issues with trial conduct.”

Publications

• Zhao J, Zhang D, Lu YY, Jin R, Li F, Zhang Z, Ni W, Gong N, Wang Y, Yin Z, Du Y, Ma W, Wang X, Zu L, Liu S, Yang K, Bai Y, Gan J, Adrian F, Hong Z, Zhang S, Chang Y, Wang Z, Jin X, Zhong J, Ge K, Peng S, Ding D, Zheng W, Xu S, Wang W, Schweizer L, Zhang H. HFB301001, an OX40-based immunotherapy, drives Treg clearance and CTL activation through optimized OX40 receptor clustering. J Immunother Cancer. 2026 Mar 30;14(3):e014185. doi: 10.1136/jitc-2025-014185.

Drugs

Indications