NCT06935409

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

A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of HS-20093 for Injection Versus Gemcitabine in Combination With Docetaxel in the Treatment of Osteosarcoma After Previous Second-line Treatment Failure (ARTEMIS-011)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, controlled, open-label, multicenter phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection versus gemcitabine in combination with docetaxel in patients (≥ 12 years old) with osteosarcoma who have at least second-line treatment failure. Eligible study participants shall be randomized in a 2:1 ratio to the experimental group and the control group. Study participants in the experimental group received HS-20093 at 12.0 mg/kg once every 3 weeks (Q3W), and the study participants continued to receive treatment until objective disease progression or other criteria for treatment discontinuation were met. Study participants in the control group received standard chemotherapy regimen of gemcitabine in combination with docetaxel until disease progression or other criteria for treatment discontinuation were met. The efficacy and safety of the two groups were evaluated after follow-up as per the procedures.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	HS-20093	Study participants in the experimental group shall continue to receive HS-20093 by intravenous infusion at a dose of 12.0 mg/kg, once every 3 weeks (Q3W) with a 21-day treatment cycle. Treatment shall continue until objective disease progression (excluding cases of treatment beyond PD or crossover treatment) or until other criteria for termination of study treatment specified in the protocol are met.
DRUG	Gemcitabine combined with docetaxel	Study participants in the control arm will receive gemcitabine in combination with docetaxel. Gemcitabine (1000 mg/m2) will be administered intravenously over approximately 30 minutes on Days 1 and 8 of each 21-day treatment cycle, followed by docetaxel (75 mg/m2) on Day 8, intravenously over approximately 1 hour until objective disease progression or other criteria for treatment discontinuation are met.

Timeline

• Start date: 2025-04-25
• Primary completion: 2026-08-31
• Completion: 2027-10-31
• First posted: 2025-04-20
• Last updated: 2026-04-09

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study