NCT06336707

HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,048 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6. This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors.

Detailed description

This study contains four combination therapy cohorts, each consisting of a dose exploration part and a dose expansion part. The dose exploration part will explore the corresponding optimal dose level of HS-20089 in each combination therapy. The dose expansion part will be conducted at 1 or 2 safe and potentially effective dose levels in subjects with selected tumors in each cohort. The cohorts may be adjusted based on the observed clinical results, translational medicine data and research progress in the field.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	HS-20089	Intravenous infusion
DRUG	Adebrelimab	Intravenous infusion
DRUG	Bevacizumab	Intravenous infusion
DRUG	Cisplatin / carboplatin	Intravenous infusion

Timeline

• Start date: 2024-04-11
• Primary completion: 2026-04-08
• Completion: 2028-04-08
• First posted: 2024-03-29
• Last updated: 2024-07-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study