RecruitingPhase 1NCT06927570

A Study of HS-20122 in Patients With Advanced Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20122 in Patients With Advanced Solid Tumors

Sponsor

Hansoh BioMedical R&D Company

Enrollment

1,050 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

Summary

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

Min Age: 18 Years

Inclusion Criteria9

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 Criteria37

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

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Interventions

DRUGHS-20122

Intravenous (IV) administration of HS-20122 ; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.