Last updated: February 13, 2023
Sponsor: Shanghai Hansoh Biomedical Co., Ltd
Overall Status: Active - Recruiting
Phase
1
Condition
Neoplasms
Treatment
N/AClinical Study ID
NCT05276609
HS-20093-101
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- At least age of 18 years at screening;
- Histologically or cytologically confirmed, locally advanced or metastatic solid tumorsfor which standard treatment either does not exist or has proven ineffective orunavailable 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 ofnon-childbearing potential
- Signed and dated Informed Consent Form
Exclusion
Exclusion Criteria: 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 14days prior to the first scheduled dose of HS-20093
- Prior treatment with a monoclonal antibody within 28 days prior to the firstscheduled dose of HS-20093
- Radiotherapy with a limited field of radiation for palliation within 2 weeks, orpatients received more than 30% of the bone marrow irradiation, or large-scaleradiotherapy 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 scheduleddose of HS-20093
- Known active infection requiring antibodies treatment within 2 weeks, or severeinfection 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 idiosyncrasyto 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 firstscheduled dose of HS-20093
- Unlikely to comply with study procedures, restrictions, and requirements in theopinion of the investigator
- Any disease or condition that, in the opinion of the investigator, would compromisesubject safety or interfere with study assessments
Study Design
Total Participants: 177
Study Start date:
November 28, 2021
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing 100021
ChinaActive - Recruiting

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