Actively Recruiting
ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors
Led by Hansoh BioMedical R&D Company · Updated on 2024-08-20
120
Participants Needed
15
Research Sites
101 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. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant Prostate Cancer. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.
CONDITIONS
Official Title
ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older
- Locally advanced or metastatic solid tumors confirmed by histology or cytology
- Standard treatments are invalid, unavailable, or intolerable for the tumor
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Agree to provide fresh or archival tumor tissue for analysis
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Estimated life expectancy of at least 12 weeks
- Use adequate contraceptive measures during the study
- Female participants must not be pregnant or be of childbearing potential
- Signed and dated informed consent form
You will not qualify if you...
- Prior or current treatment with B7-H3 targeted therapy
- Cytotoxic chemotherapy, investigational agents, or anticancer drugs within 14 days before first HS-20093 dose
- Monoclonal antibody treatment within 28 days before first HS-20093 dose
- Radiotherapy involving large bone marrow areas within 4 weeks or limited field radiotherapy within 2 weeks before first dose
- Presence of pleural, peritoneal, or pericardial effusion requiring intervention
- Major surgery within 4 weeks before first dose
- Spinal cord compression or brain metastases
- Use of drugs affecting CYP3A4, CYP2D6, P-gp, or BCRP enzymes with narrow therapeutic range within 7 days before first dose
- Use of drugs known to prolong QT interval or cause torsade de pointe
- Patients with BRCA and ATM mutations
- Unresolved toxicities greater than Grade 2 from prior therapy except alopecia or neurotoxicity
- History of other primary cancers
- Inadequate bone marrow or organ function
- Evidence of cardiovascular risk or severe cardiovascular disease
- Severe or uncontrolled diabetes or hypertension
- Significant bleeding symptoms or bleeding tendency within 1 month before first dose
- Serious arteriovenous thrombosis within 3 months before first dose
- Severe infections within 4 weeks before first dose
- Long-term steroid treatment or immunodeficiency conditions
- Active infectious diseases like hepatitis B, C, tuberculosis, syphilis, or HIV
- Hepatic encephalopathy, hepatorenal syndrome, or advanced liver cirrhosis
- Severe urinary diseases affecting urinary function or drug toxicity detection
- History of serious neuropathy or mental disorders
- Pregnant or breastfeeding women
- Vaccination or hypersensitivity within 4 weeks before first dose
- Severe hypersensitivity or allergy to human or mouse proteins or to HS-20093 ingredients
- Unlikely to comply with study procedures or safety concerns as judged by investigator
- Any condition compromising subject safety or study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Peking University Cancer Hospital
Beijing, China
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, China
Actively Recruiting
3
Xiangya Hospital Central South University
Changsha, China
Actively Recruiting
4
West China hospital, sichuan university
Chengdu, China
Actively Recruiting
5
The First Affiliate Hospital of GUANGZHOU Medical University
Guangzhou, China
Actively Recruiting
6
Yunnan Cancer Hospital
Kunming, China
Actively Recruiting
7
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, China
Actively Recruiting
8
Guangxi Medical University Cancer Hospital
Nanning, China
Actively Recruiting
9
Fudan University Cancer Hospital
Shanghai, China, 200032
Actively Recruiting
10
Liaoning Tumor Hospital
Shengyang, China
Actively Recruiting
11
Shengjing Hospital of China Medical University
Shengyang, China
Actively Recruiting
12
The First Hospital of China Medical University
Shengyang, China
Actively Recruiting
13
Hubei Cancer Hospital
Wuhan, China
Actively Recruiting
14
Tongji Hospital
Wuhan, China
Actively Recruiting
15
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
W
Weijing Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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