ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas

Sponsor
Hansoh BioMedical R&D Company
Study ID
NCT05830123
Phase
PHASE2
Status
Recruiting
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Conditions

  • Osteosarcoma
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HS-20093 — DRUG
    IV administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Study Details

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with relapsed or refractory osteosarcoma and other sarcomas.

Key Dates

First listed
Apr 26, 2023
Start date
Jun 8, 2023
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: cohort 1 at HS-20093 8mg/kg (Phase 2a)
    Participants in cohort 1 will be randomized to receive HS-20093 at 8 mg/kg.
  • Experimental: cohort 1 at HS-20093 12mg/kg (Phase 2a)
    Participants in cohort 1 will be randomized to receive HS-20093 at 12 mg/kg.
  • Experimental: cohort 2 at HS-20093 12mg/kg (Phase 2a)
    Participants in cohort 2 will receive HS-20093 at 12 mg/kg.
  • Experimental: HS-20093(Phase 2b)
    Participants will receive HS-20093 at the recommended dose from Phase 2a.

Primary Outcome Measure

Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months. ]

Central Contacts

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