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

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20122 in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: HS-20122

• Study Type: Interventional
• Enrollment (Estimated): 1050
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ketao Chen; Phone Number: 18795500836; Email: chenkt@hspharm.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Ethics Committee of Sun Yat-sen University Cancer Center
      • Contact: Xuzhi Pan; Phone Number: 020-87343009; Email: llwyh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-20122; All subjects will receive HS-20122 in a continuous regimen in dose escalation stage or dose expansion stage	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum tolerated dose (MTD) or the maximum applicable dose (MAD)	To determine the MTD or MAD for further evaluation of intravenous administration of HS-20122 in subjects with advanced solid tumors	From time of first dose of HS-20122 to end of DLT period (approximately 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	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	up to 24 months
Incidence and severity of adverse events (AEs)	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.	From time of Informed Consent to 28 days post last dose of HS-20122
Incidence of dose-limiting toxicities (DLT) as defined in the protocol	Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol	From time of first dose of HS-20122 to end of DLT period (approximately 21 days)
Observed maximum drug concentration (Cmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)	The Cmax is the maximum observed drug concentration of HS-20122	From the date of first dose until 30 days after the final dose
Time to reach maximum observed drug concentration (Tmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)	The Tmax is defined as time to reach maximum observed drug concentration of HS-20122.	From the date of first dose until 30 days after the final dose.
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)	The AUC0-t is defined as the area under the drug concentration-time curve during a dose interval time period(t)	From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose.
Area under the curve from time Zero to end of dosing interval (AUC0-∞) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)	The AUC0-∞ is defined as the area under the drug concentration-time curve from time 0 to infinity	From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose
Incidence of anti-HS-20122 antibody (ADA)	ADA incidence was defined as the percentage of participants whose ADA status were identified as positive.	From the date of first dose until 30 days after the final dose.

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Solid Tumors; HS-20122
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HS-20122-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No