Status:
NOT_YET_RECRUITING
A Study of HS-20122 in Patients With Advanced Solid Tumors
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 eff...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT06927570
Start Date
May 9 2025
End Date
June 30 2028
Last Update
April 15 2025
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