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

Overview

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.

Interventions

• 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.

Primary outcome measures

• The maximum tolerated dose (MTD) or the maximum applicable dose (MAD) [Time frame: From time of first dose of HS-20122 to end of DLT period (approximately 21 days)]

Secondary outcome measures (8)

• Incidence and severity of adverse events (AEs) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose]
• Incidence of anti-HS-20122 antibody (ADA) [Time frame: From the date of first dose until 30 days after the final dose.]
• Objective response rate (ORR) [Time frame: up to 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Ethics Committee of Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT06927570 · HS-20122-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗