Peking University’s Dr. Xie Unveils ARTEMIS-002 Trial for Sarcomas

Dr. Lu Xie, a medical oncologist at Peking University People’s Hospital, recently outlined the objectives and design of the phase 2 ARTEMIS-002 trial (NCT05830123). This clinical study is assessing the efficacy of the B7-H3–targeted antibody-drug conjugate (ADC) HS-20093 in patients diagnosed with relapsed or refractory sarcomas. Notably, this trial marks the first clinical examination of HS-20093 within this specific patient demographic.

The ARTEMIS-002 trial builds on positive outcomes from the earlier phase 1 ARTEMIS-001 trial (NCT05276609), which demonstrated objective responses in various sarcoma subtypes, including osteosarcoma, at doses of 8 mg/kg and 12 mg/kg. These findings were accompanied by an acceptable safety profile, prompting further investigation.

Trial Structure and Cohorts

Cohort 1 of ARTEMIS-002 focuses on patients with relapsed or refractory osteosarcoma. This group aims to identify the optimal dosing strategy by comparing the efficacy and tolerability of two different doses: 8 mg/kg and 12 mg/kg of HS-20093. Early results from ARTEMIS-001 suggested enhanced clinical activity at the higher 12 mg/kg dose, although safety profiles remained similar between both doses. To validate these preliminary findings, the trial expanded by including an additional 10 patients in cohort 3, which aims to further explore the efficacy, duration of response, and any dose-related toxicities linked to the ADC.

Cohort 2 consists of adult patients with other relapsed or refractory sarcoma subtypes, excluding osteosarcoma. Participants in this cohort are being treated with HS-20093 at the recommended phase 2 dose (RP2D) of 12 mg/kg. The primary goals of the trial are to assess the objective response rate and safety across a wider sarcoma population while confirming the RP2D established in earlier research.

To enhance the study’s insights, the design was refined to include cohort 3, which targets adolescent and young adult patients with osteosarcoma. Dr. Xie highlighted that this age group is particularly affected by osteosarcoma, and their inclusion aims to examine both the immunogenicity and pharmacokinetic profile of HS-20093 in younger patients.

Future Implications of the Study

Through this structured approach, the ARTEMIS-002 trial aims to define the efficacy, safety, and optimal dosing of HS-20093 among both adult and adolescent populations. The outcomes are anticipated to provide crucial information for future late-phase development and may support the advancement of B7-H3–directed ADC therapy as a promising treatment option for patients dealing with relapsed or refractory sarcomas.

Dr. Xie’s insights reaffirm the importance of ongoing clinical research in improving therapeutic strategies for challenging cancer types, highlighting a commitment to addressing unmet medical needs in oncology.