Study of HS-20093 Versus Gemcitabine in Combination With Docetaxel in Treatment of Osteosarcoma After Previous Second-line Treatment Failure

Summary

This is a randomized, controlled, open, multicenter phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection versus gemcitabine in combination with docetaxel in patients with osteosarcoma who have at least second-line treatment failure.

Timeline

Start

2025-04-25

Primary completion

2026-08-31

Completion

2027-10-31

Outcome

Met primary endpoint

release “met the primary endpoint of progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) in the pivotal Phase III clinical trial (ARTEMIS-011)” hspharm.com ↗

release “翰森制药 | B7-H3 ADC Risvutatug Rezetecan（HS-20093）骨肉瘤III期临床ARTEMIS-011达到IRC-PFS主要终点” hansoh.cn ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Docetaxel	Small molecule	75 mg/m2	Intravenous
Comparator	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	HS-20093	Other / unclassified	12 mg/kg	Intravenous

Indications