Clinical trial NCT06927570: A Study of HS-20122 in Patients With Advanced Solid Tumors
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20122 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced Solid Tumors
HS-20122
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 efficacy of HS-20122 in advanced solid tumors.


Eligibility criteria: 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 outcomes:
measure: The maximum tolerated dose (MTD) or the maximum applicable dose (MAD)
timeFrame: From time of first dose of HS-20122 to end of DLT period (approximately 21 days)
Secondary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: From time of Informed Consent to 28 days post last dose of HS-20122
measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol
timeFrame: From time of first dose of HS-20122 to end of DLT period (approximately 21 days)
measure: Observed maximum drug concentration (Cmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
timeFrame: From the date of first dose until 30 days after the final dose
measure: Time to reach maximum observed drug concentration (Tmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
timeFrame: From the date of first dose until 30 days after the final dose.
measure: Area under the curve from time Zero to end of dosing interval (AUC0-t) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
timeFrame: From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose.
measure: Area under the curve from time Zero to end of dosing interval (AUC0-∞) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
timeFrame: From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose
measure: Incidence of anti-HS-20122 antibody (ADA)
timeFrame: From the date of first dose until 30 days after the final dose.
measure: Objective response rate (ORR)
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
References: