Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05830123
Status:
RECRUITING
Last Update Posted:
2023-07-20
First Post:
2023-04-03
Brief Title:
ARTEMIS-002 HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas
Sponsor:
Hansoh BioMedical RD Company
Organization:
Hansoh BioMedical RD Company
Study Overview
Official Title:
ARTEMIS-002 A Phase 2 Multicenter Open-label Study of Intravenous Administration of HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This is a phase 2 open-label multi-center study consisting of two parts Phase 2a and 2b
Phase 2a The study will be conducted in the following two cohorts Cohort 1 Patients with advanced osteosarcoma upon disease progression after standard treatment Cohort 2 Patients with other unresectable bone and soft tissue sarcomas if they have progressed on or intolerant to available standard therapies or no standard or available curative therapy exists Subjects will be randomly assigned in a 11 ratio to 80 mgkg and 120 mgkg of HS-20093 in cohort 1 and will receive 120 mgkg in cohort 2
Phase 2b The study will be conducted in patients with advanced osteosarcoma upon disease progression after standard treatment Subjects will receive HS-20093 at the recommended dose from Phase 2a
All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of HS-20093 Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists
Phase 2a The study will be conducted in the following two cohorts Cohort 1 Patients with advanced osteosarcoma upon disease progression after standard treatment Cohort 2 Patients with other unresectable bone and soft tissue sarcomas if they have progressed on or intolerant to available standard therapies or no standard or available curative therapy exists Subjects will be randomly assigned in a 11 ratio to 80 mgkg and 120 mgkg of HS-20093 in cohort 1 and will receive 120 mgkg in cohort 2
Phase 2b The study will be conducted in patients with advanced osteosarcoma upon disease progression after standard treatment Subjects will receive HS-20093 at the recommended dose from Phase 2a
All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of HS-20093 Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None