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

NCT06927570 | Recruiting Phase 1

• 1 other identifier: HS-20122-101
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors; HS-20122

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence and severity of adverse events (AEs)

  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

  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)

  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)

  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)

  From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose.

Study Arms (1)

HS-20122

EXPERIMENTAL

All subjects will receive HS-20122 in a continuous regimen in dose escalation stage or dose expansion stage

Drug: HS-20122

Interventions

HS-20122 DRUG

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.

HS-20122

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Ethics Committee of Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

Ketao Chen

CONTACT

18795500836; chenkt@hspharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CN (1)