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)
The maximum tolerated dose (MTD) or the maximum applicable dose (MAD) — From time of first dose of HS-20122 to end of DLT period (approximately 21 days) To determine the MTD or MAD for further evaluation of intravenous administration of HS-20122 in subjects with advanced solid tumors
Trial sites (1)
Facility
City
Region
Status
Ethics Committee of Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
More Hansoh BioMedical R&D Company trials in China
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.