NCT04866485

A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combined With Anti-PD-1 Antibody

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center phase 1 study. The trial, consisting of Part 1a dose confirmation and Part 1b dose expansion, is designed to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 in combination with pembrolizumab in patients with advanced NSCLC and other solid tumors.

Detailed description

subjects will be treated with HBM4003 in combination with pembrolizumab 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: * Part 1a dose confirmation study * Part 1b dose expansion study * A post-treatment follow-up period, including * A safety follow-up period: 28 days after the last dose of study drug; * Post-treatment follow-up visit: day 84 after the last dose of study drug; * Survival follow-up.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	HBM4003 and pembrolizumab	Subjects will be treated with HBM4003 and pembrolizumab on Day 1 during each 21-day cycles.

Timeline

• Start date: 2021-06-14
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2021-04-29
• Last updated: 2021-04-29