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

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: HS-20122（Phase 1a：Dose Escalation）; Drug: HS-20122（Phase 1b：Dose Expansion ）

• Registration Number: NCT06927570
• Lead Sponsor: Hansoh BioMedical R&D Company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Study Start: 2025-05-09
• Primary Completion: 2028-01-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1050

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HS-20122（Phase 1a：Dose Escalation）	HS-20122（Phase 1a：Dose Escalation）	All subjects will receive HS-20122 in a continuous regimen in dose escalation stage
HS-20122（Phase 1b：Dose Expansion ）	HS-20122（Phase 1b：Dose Expansion ）	All subjects will receive HS-20122 in a continuous regimen in dose expansion stage

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)	From time of Informed Consent to 28 days post last dose of HS-20122	Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0.
Incidence of dose-limiting toxicities (DLT) as defined in the protocol	From time of first dose of HS-20122 to end of DLT period (approximately 21 days)	Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Observed maximum drug concentration (Cmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)	From the date of first dose until 30 days after the final dose	The Cmax is the maximum observed drug concentration of HS-20122
Time to reach maximum observed drug concentration (Tmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)	From the date of first dose until 30 days after the final dose.	The Tmax is defined as time to reach maximum observed drug concentration of HS-20122.
Area under the curve from time Zero to end of dosing interval (AUC0-∞) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)	From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose	The AUC0-∞ is defined as the area under the drug concentration-time curve from time 0 to infinity
Objective response rate (ORR)	up to 24 months	ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Incidence of anti-HS-20122 antibody (ADA)	From the date of first dose until 30 days after the final dose.	ADA incidence was defined as the percentage of participants whose ADA status were identified as positive.
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)	From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose.	The AUC0-t is defined as the area under the drug concentration-time curve during a dose interval time period(t)