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
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• At least age of 18 years at screening;
• Patients with histologically confirmed relapsed or refractory osteosarcoma or other sarcomas who have progressed upon first-line systemic treatment.
• At least one measurable lesion according to RECIST 1.1.
• Agree to provide fresh or archival tumor tissue and peripheral blood samples.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\
⁃ 1
• Life expectancy \>= 12 weeks
• Men or women should be using adequate contraceptive measures throughout the study;
• Females subjects must not be pregnant at screening or have evidence of non-childbearing potential
• Signed and dated Informed Consent Form
Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
First Affiliated Hospital, Sun Yat-Sen University
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Chinese PLA General Hospital of Eastern Theater Command
RECRUITING
Nanjing
Shanghai 6th People's Hospital
RECRUITING
Shanghai
Shanghai General Hospital
RECRUITING
Shanghai
Tianjin Cancer Hospital
RECRUITING
Tianjin
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Wei Guo, MD
bonetumor@163.com
010-88326656
Backup
Cuicui Cong
rmyyllwyh@163.com
01088324516
Time Frame
Start Date:2023-06-08
Estimated Completion Date:2027-12-31
Participants
Target number of participants:170
Treatments
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.