NCT06112704

HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors

A Phase 2, Open-label, Multi-center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors (ARTEMIS-005)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety, pharmacokinetics and immunogenicity of HS-20093 in Chinese advanced esophageal carcinoma and other solid tumor patients.

Detailed description

This is an open-label, multi-center phase 2 study in Chinese adult participants with recurrent, locally advanced or metastatic esophageal carcinoma or other advanced solid tumors, which is designed to investigate the efficacy, safety, pharmacokinetics and immunogenicity of HS-20093. This study will consist of two parts: phase IIa and phase IIb. Part 1 (phase IIa) will conducted in participants with relapsed, locally advanced or metastatic esophageal carcinoma and other advanced solid tumor. Subjects will receive one dose levels of HS-20093 intravenously every 3 weeks. Part 2 (phase IIb) will enroll participants with relapsed, locally advanced or metastatic esophageal squamous cell carcinoma. One dose levels of HS-20093 will be administered as an intravenous (IV) infusion every 3 weeks.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HS-20093	Intravenous (IV) infusion of HS-20093 Q3W; Participants will receive continuous treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Timeline

• Start date: 2024-02-06
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2023-11-01
• Last updated: 2024-12-02

Locations

21 sites across 1 country: China