NCT05167071

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

An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Toripalimab/ Tislelizumab in Patients With Advanced NEN and Other Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

Subjects will be treated with HBM4003 in combination with Toripalimab for up to 2 years or until confirmed disease progression, unacceptable tolerability or treatment discontinuation through withdrawal of consent occurs, whichever happens first. This trial consists of: * A screening period: 28 days * A treatment period: no longer than 2 years (Part 1 dose escalation study or Part 2 dose expansion) * A post-treatment follow-up period, including 28 days and 84 days after the last dose of study drug; * Survival follow-up.

Conditions

• Solid Tumors
• Neuroendocrine Tumors
• CRC

Interventions

Type	Name	Description
DRUG	HBM4003	Subjects will be treated with HBM4003 on Day 1 during each 21-day cycle.
DRUG	Toripalimab	Subjects will be treated with Toripalimab on Day 1 during each 21-day cycle.
DRUG	Tislelizumab	Subjects will be treated with Tislelizumab on Day 1 during each 21-day cycle.

Timeline

• Start date: 2021-12-28
• Primary completion: 2025-09-30
• Completion: 2026-06-30
• First posted: 2021-12-22
• Last updated: 2025-04-27

Locations

1 site across 1 country: China