Skip to main content
CTOS 2023 Main banner
Final Program


Schedule at a Glance
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back

Bone Sarcomas

(P 52) ARTEMIS-002 TRIAL IN PROGRESS: A MULTI-CENTER PHASE II TRIAL ASSESSING HS-20093 (B7-H3 ANTIBODY-DRUG CONJUGATE) FOR RELAPSED OR REFRACTORY OSTEOSARCOMA AND OTHER SARCOMAS

Location: The Liffey, Level 1

    Author(s)

  • Lu Xie, MD (she/her/hers)

    consultant and vice director of Musculoskeletal Tumor Center
    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

    • Co-Author(s)

  • Jie Xu, MD

    Consultant
    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

  • Xs

    Xin sun, N/A, MD

    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

  • KL

    Kuisheng Liu, M.D.

    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

  • XL

    Xin Liang, M.D.

    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

  • Xiaodong Tang, M.D.

    Chief
    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

  • WG

    Wei Guo, N/A, M.D.

    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

Objective: this phase II trial is intended to investigate the activity of the B7-H3-targeting ADC HS-20093 in these sarcomas, with special attention on osteosarcoma patients.

Methods: ARTEMIS-002 trial is a national multiple-center, two-arm phase II trial in pts with R/R osteosarcoma or other sarcomas progressed upon first-line systemic treatment, which is consisted of two phases. Phase IIa (the proof of concept study) contains two arms, of which one arm contains osteosarcoma only and the other includes all kinds of sarcoma pts. Based on the results of our phase I trial that the maximum tolerated dose (MTD) was 16mg/kg once every 3 weeks (Q3W) intravenous infusion, the osteosarcoma pts in arm one will be randomly assigned 1:1 to receive HS-20093 either at 8 mg/kg or 12 mg/kg Q3W, and the sarcoma pts in arm two will receive 12 mg/kg Q3W. An estimated number of 60 pts will be enrolled in phase IIa trial, with about 20 pts in every dose cohort. We will further identify the better dose based on phase IIa study for osteosarcoma by balancing the efficacy and the safety and use the dose for Phase IIb for about 80 osteosarcoma pts. Key eligibility criteria are age ≥18 years, histologically confirmed osteosarcoma or other sarcomas, ECOG performance status 0-1, measurable disease per RECIST 1.1. The primary endpoint is the objective response rate (ORR) per RECIST 1.1 by independent review committee. Secondary endpoints include disease control rate (DOR), duration of response (DoR), progression free survival (PFS) and overall survival (OS). Safety, pharmacokinetics and immunogenicity will also be assessed as the other secondary endpoints. Exploratory studies are designed to evaluate the correlation between exposure and responses to HS-20093, and explore the potential efficacy biomarker (B7-H3 protein expression, soluble B7-H3 concentration, PD-L1 protein expression and genetic abnormality) of HS-20093.Clinical trial information: NCT05830123.

Results: N/A Now the trial is enrolling.

Conclusion: N/A Now the trial is enrolling.