NCT06332170

ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors

ARTEMIS-101: A Phase 1, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of HS-20093 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 610 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HS-20093 is a fully 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 safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients.

Detailed description

This is a phase 1, open-label, multi-center, dose-escalation and expansion, phase 1 study in Chinses subjects with advanced solid tumors. This study is in design allowing assessment of safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents. A total of 5 combination-treatments will be carried out in 3 cohorts. The target population of dose escalation part is patients have progressed on or intolerant to available standard therapies, and the dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease. All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HS-20093	administered as an IV infusion
DRUG	Adebrelimab	administered as an IV infusion
DRUG	Cisplatin/ Carboplatin	administered as an IV infusion
DRUG	Cetuximab	administered as an IV infusion
DRUG	Enzalutamide	160mg once daily (QD) orally

Timeline

• Start date: 2024-04-26
• Primary completion: 2026-05-30
• Completion: 2028-05-30
• First posted: 2024-03-27
• Last updated: 2024-07-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study