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Clinical Trials in China / NCT06927570
Recruiting Phase 1

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

NCT06927570 · tracked via the Priya Life Science China tracker
Sponsor
Hansoh BioMedical R&D Company
Phase
Phase 1
Started
2025-04-15
Last updated
2026-01-16

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

HS-20122

HS-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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ethics Committee of Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06927570 on ClinicalTrials.gov ↗ ← All trials in China