HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors
A Phase 2, Open-label, Multi-center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors (ARTEMIS-005)
Hansoh BioMedical R&D Company
220 participants
Feb 6, 2024
INTERVENTIONAL
Conditions
Summary
HS-20093 is a 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, pharmacokinetics and immunogenicity of HS-20093 in Chinese advanced esophageal carcinoma and other solid tumor patients.
Eligibility
Inclusion Criteria10
- Men or women aged more than or equal to (≥) 18 years.
- Histologically or cytologically confirmed, relapsed, locally advanced or metastatic esophageal carcinomas and other advanced solid tumor.
- At least one extra measurable lesion according to RECIST 1.1 (cavity structures such as oesophagus cannot serve as measurable lesions).
- Agree to provide fresh or archival tumor tissue and blood samples.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.
- Estimated 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 Criteria17
- 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 Local radiotherapy for palliation within 2 weeks of the first dose of study drug, 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
- Significant tumor invasion into adjacent organs (aorta or trachea) of esophageal lesions leading to higher risk of bleeding or fistula
- 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
- Severe infections occured within 4 weeks before the first dose
- The presence of active infectious diseases has been known before first dose such as hepatitis B, hepatitis C, ect
- 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
Interventions
Intravenous (IV) infusion of HS-20093 Q3W; Participants will receive continuous treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Locations(21)
View Full Details on ClinicalTrials.gov
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NCT06112704