Actively Recruiting
ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas
Led by Hansoh BioMedical R&D Company · Updated on 2024-08-23
170
Participants Needed
11
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening
- Histologically confirmed relapsed or refractory osteosarcoma or other sarcomas with progression after first-line systemic treatment
- At least one measurable tumor lesion according to RECIST 1.1
- Willing to provide fresh or archival tumor tissue and blood samples
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Life expectancy of at least 12 weeks
- Use of adequate contraceptive measures throughout the study for men and women
- Female participants must not be pregnant and must have evidence of non-childbearing potential
- Signed and dated informed consent form
You will not qualify if you...
- Previous or current treatment with B7-H3 targeted therapy
- Any cytotoxic chemotherapy, investigational agents, or anticancer drugs within 14 days before first HS-20093 dose
- Prior monoclonal antibody treatment within 28 days before first HS-20093 dose
- Radiotherapy within 2 weeks if limited field for palliation, or large-scale radiotherapy within 4 weeks before first HS-20093 dose
- Pleural or peritoneal effusion requiring clinical intervention or pericardial effusion
- Major surgery within 4 weeks before first HS-20093 dose
- Spinal cord compression or brain metastases
- Use of strong CYP3A4 inhibitors, inducers, or sensitive substrates within 7 days before first HS-20093 dose or during study
- Use of drugs known to prolong QT interval or cause torsade de pointe during study
- Unresolved toxicities from prior therapy greater than Grade 2 except alopecia or neurotoxicity
- History of other primary cancers
- Inadequate bone marrow or organ function
- Evidence of cardiovascular risk or severe uncontrolled cardiovascular diseases
- Diabetes ketoacidosis or hyperglycemia within 6 months before first HS-20093 dose or HbA1c ≥7.5% at screening
- Severe or poorly controlled hypertension
- Significant bleeding symptoms within 1 month before first HS-20093 dose
- Serious arteriovenous thrombosis events within 3 months before first HS-20093 dose
- Severe infections within 4 weeks before first HS-20093 dose
- Continuous steroid treatment over 30 days within 30 days before first HS-20093 dose or need for long-term steroids
- Known active infections like hepatitis B, C, tuberculosis, syphilis, or HIV before first HS-20093 dose
- Hepatic encephalopathy, hepatorenal syndrome, or severe liver cirrhosis
- Moderate or severe lung diseases affecting respiratory function
- History of serious neurological or mental disorders interfering with assessment
- Women who are pregnant, breastfeeding, or planning pregnancy during study
- Vaccination or hypersensitivity within 4 weeks before first HS-20093 dose
- History of severe allergic reactions to human or mouse proteins
- Allergy to any ingredient of HS-20093
- Unlikely to comply with study procedures or with conditions compromising safety or assessments as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, China
Actively Recruiting
3
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Actively Recruiting
4
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
5
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Actively Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
7
Chinese PLA General Hospital of Eastern Theater Command
Nanjing, China
Actively Recruiting
8
Shanghai 6th People's Hospital
Shanghai, China
Actively Recruiting
9
Shanghai General Hospital
Shanghai, China
Actively Recruiting
10
Tianjin Cancer Hospital
Tianjin, China
Actively Recruiting
11
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
W
Wei Guo, MD
CONTACT
C
Cuicui Cong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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