HBM4003 Combine With Toripalimab in Patients With Advanced NEN and Other Solid Tumors Study

Phase 1 Active not recruiting 53 enrolled Harbour BioMed (Guangzhou) Co. Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

To select RP2D/MTD of HBM4003 in combination with Toripalimab in dose confirmation part(Part 1) and use the RP2D in dose expansion part (Part 2) to evaluate the safety, tolerability, PK/PD and preliminary efficacy of in patients with advanced NEN and other solid tumors

Timeline

Start: 2021-12-28
Primary completion: 2025-09-30
Completion: 2026-06-30

Publications

Zhang P, Chen K, Yang J, Song L, Zheng F, Luo R, He Y, Li F, Yang D, Cao N, Tao X, Shen L, Lu M. Efficacy and safety of HBM4003 combined with toripalimab in refractory neuroendocrine neoplasms: a multicenter, phase II study. EClinicalMedicine. 2025 Jun 3;84:103249. doi: 10.1016/j.eclinm.2025.103249. eCollection 2025 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PORUSTOBART	Monoclonal antibody	0.3 mg/kg	—
Subject	PORUSTOBART	Monoclonal antibody	0.45 mg/kg	—
Subject	Tislelizumab	Monoclonal antibody	—	—
Subject	Toripalimab	Monoclonal antibody	240 mg	—

HBM4003 Combine With Toripalimab in Patients With Advanced NEN and Other Solid Tumors Study

Summary

Timeline

Publications

Drugs

Indications