Not Yet RecruitingPhase 1

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

448 participantsStarted 2024-12-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Cohort1: Dose escalation part will enroll advanced soft tissue sarcoma for which standard treatment has proven ineffective or unavailable or intolerable. Dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
✓. Cohort2: Advanced osteosarcoma patients for which standard treatment has proven ineffective or unavailable or intolerable.

Exclusion criteria

✕. Previous or current treatment with B7-H3 targeted therapy
✕. Previous or current treatment with TOP1i related treatment
✕. Previous or current treatment with PD-L1 inhibitor (Cohort2 )
✕. Intolerable for any Anlotinib(Cohort 1a/1c), Anthracyclines (Cohort 1b/1c) and PD-L1 inhibitor (Cohort2 )
✕. Cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093
✕. Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093
✕. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093
✕. Major surgery within 4 weeks prior to the first scheduled dose of HS-20093

What they're measuring

Maximum tolerated dose (MTD) for combination-treatments

Timeframe: Up to day 21 from the first dose

Trial details

NCT IDNCT06699576

SponsorHansoh BioMedical R&D Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Xiaodong Tang, PhD

010-88324561 tang15877@126.com

View on ClinicalTrials.gov More Osteosarcoma trials