Overview

This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors.

Eligibility

Inclusion Criteria:

• Males or females, aged ≥ 18 years.
• Subjects with histologically or cytologically confirmed locally advanced or metastatic Solid Tumors
• Standard treatment is invalid, unavailable or intolerable.
• At least 1 target lesion according to RECIST 1.1.
• ECOG PS score: 0-1.
• Estimated Life expectancy\> 12 weeks.
• Men or women should be using adequate contraceptive measures throughout the study.
• Women must have the evidence of non-childbearing potential.
• Signed and dated Informed Consent Form.

Exclusion Criteria:

• Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity
• History of other primary malignancies.
• Inadequate bone marrow reserve or organ dysfunction.
• Evidence of cardiovascular risk.
• Subjects with severe or poorly controlled diabetes.
• Subjects with severe or poorly controlled hypertension.
• Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.
• Subjects with severe arteriovenous thrombotic events within 3 months.
• Subjects with severe infection within 4 weeks prior to the first dose.
• Subjects who have received steroid therapy for more than 30 days .
• Presence of known active infectious diseases.
• Presence of clinically significant gastrointestinal dysfunction.
• Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B.
• Moderate to severe pulmonary diseases.
• Prior history of significant neurological or mental disorders.
• Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
• Hypersensitivity to any ingredient of HS-20122.
• 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 Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity
• History of other primary malignancies.
• Inadequate bone marrow reserve or organ dysfunction.
• Evidence of cardiovascular risk.
• Subjects with severe or poorly controlled diabetes.
• Subjects with severe or poorly controlled hypertension.
• Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.
• Subjects with severe arteriovenous thrombotic events within 3 months.
• Subjects with severe infection within 4 weeks prior to the first dose.
• Subjects who have received steroid therapy for more than 30 days .
• Presence of known active infectious diseases.
• Presence of clinically significant gastrointestinal dysfunction.
• Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B.
• Moderate to severe pulmonary diseases.
• Prior history of significant neurological or mental disorders.
• Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
• Hypersensitivity to any ingredient of HS-20122.
• 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