NCT06699576

ARTEMIS-103: Phase 1b Study of HS-20093 Combinations in Patients with Bone and Soft Tissue Sarcoma.

ARTEMIS-103: a Phase 1b, 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 Bone and Soft Tissue Sarcoma.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 448 (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 bone and soft tissue sarcoma. 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 bone and soft tissue sarcoma.

Detailed description

This is a phase 1b, open-label, multi-center, dose-escalation and expansion study in subjects with advanced bone and soft tissue sarcoma. 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 4 combination-treatments will be carried out in 2 cohorts. The target population in cohort 1 of dose escalation part is soft tissue sarcoma 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. The target population in cohort 2 will enroll patients with osteosarcoma have progressed on or intolerant to available standard therapies 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

• Osteosarcoma
• Soft Tissue Sarcoma (STS)

Interventions

Type	Name	Description
DRUG	HS-20093	HS-20093: administered as an IV infusion
DRUG	Anlotinib	Anlotinib: 12mg once daily (QD) orally
DRUG	Epirubicin	Epirubicin: administered as an IV infusion
DRUG	Adebrelimab	Adebrelimab: administered as an IV infusion

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-12-30
• Completion: 2028-12-30
• First posted: 2024-11-21
• Last updated: 2024-11-21