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

Sponsor
Hansoh BioMedical R&D Company
Study ID
NCT06699576
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Osteosarcoma
  • Soft Tissue Sarcoma (STS)

Eligibility Criteria

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

Interventions

  • HS-20093 — DRUG
    HS-20093: administered as an IV infusion
  • Anlotinib — DRUG
    Anlotinib: 12mg once daily (QD) orally
  • Epirubicin — DRUG
    Epirubicin: administered as an IV infusion
  • Adebrelimab — DRUG
    Adebrelimab: administered as an IV infusion

Study Details

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.

Key Dates

First listed
Nov 21, 2024
Start date
Dec 20, 2024
Status verified
Nov 2024
Primary completion
Dec 30, 2026
Completion
Dec 30, 2028

Study Design

Enrollment
448 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1a
    HS-20093 and Anlotinib
  • Experimental: Cohort 1b
    HS-20093 and Epirubicin
  • Experimental: Cohort 1c
    HS-20093, Epirubicin and Anlotinib
  • Experimental: Cohort 2a
    HS-20093 and Adebrelimab

Primary Outcome Measure

Maximum tolerated dose (MTD) for combination-treatments [ Time Frame: Up to day 21 from the first dose ]

Central Contacts

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