Status:
UNKNOWN
ARTEMIS-001: Phase 1 Study of the HS-20093 in Patients With Advanced Solid Tumors
Lead Sponsor:
Shanghai Hansoh Biomedical Co., Ltd
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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. The objectives of this study are to investigate the ...
Detailed Description
This is an open-label, multi-center, dose-escalation and expansion, first-in-human phase 1 study in Chinese adult participants with locally advanced or metastatic solid tumors. This study will consist...
Eligibility Criteria
Inclusion
- At least age of 18 years at screening;
- Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable
- At least one extra-cranial measurable lesion according to RECIST 1
- Agree to provide fresh or archival tumor tissue
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1
- Life expectancy \>= 12 weeks
- Agree to use medically accepted methods of contraception
- 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
Exclusion
- Any of the following would exclude the subject from participation in the study:
- Treatment with any of the following:
- Previous or current treatment with B7-H3 targeted therapy
- Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093
- Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093
- Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093
- Major surgery within 4 weeks prior to the first scheduled dose of HS-20093
- Subjects with previous or concurrent malignancies
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk
- Evidence of current severe or uncontrolled systemic diseases
- Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
- Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first scheduled dose of HS-20093
- Subjects with current infectious diseases
- History of neuropathy or mental disorders
- Pregnant or lactating female
- History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093
- Known vaccination or hypersensitivity of any level within 4 weeks prior to the first scheduled dose of HS-20093
- Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator
- Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments
Key Trial Info
Start Date :
November 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT05276609
Start Date
November 28 2021
End Date
December 31 2023
Last Update
February 15 2023
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021