🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06112704
Recruiting Phase 2

HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors

NCT06112704 · tracked via the Priya Life Science China tracker
Sponsor
Hansoh BioMedical R&D Company
Phase
Phase 2
Started
2024-02-06
Last updated
2024-12-02

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

HS-20093

HS-20093: Intravenous (IV) infusion of HS-20093 Q3W; Participants will receive continuous treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Study summary

HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety, pharmacokinetics and immunogenicity of HS-20093 in Chinese advanced esophageal carcinoma and other solid tumor patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Men or women aged more than or equal to (≥) 18 years. 2. Histologically or cytologically confirmed, relapsed, locally advanced or metastatic esophageal carcinomas and other advanced solid tumor. 3. At least one extra measurable lesion according to RECIST 1.1 (cavity structures such as oesophagus cannot serve as measurable lesions). 4. Agree to provide fresh or archival tumor tissue and blood samples. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1. 6. Estimated life expectancy \>12 weeks. 7. Agree to use medically accepted methods of contraception. 8. Men or women should be using adequate contraceptive measures throughout the study. 9. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. 10. Signed and dated Informed Consent Form. Exclusion Criteria: Any of the following would exclude the subject from participation in the study: 1. Treatment with any of the following: Previous or current treatment with B7-H3 targeted therapy Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093 Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093 Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093 Major surgery within 4 weeks prior to the first scheduled dose of HS-20093 2. Subjects with previous or concurrent malignancies 3. Significant tumor invasion into adjacent organs (aorta or trachea) of esophageal lesions leading to higher risk of bleeding or fistula 4. Inadequate bone marrow reserve or organ dysfunction. 5. Evidence of cardiovascular risk 6. Evidence of current severe or uncontrolled systemic diseases 7. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093 8. Severe infections occured within 4 weeks before the first dose 9. The presence of active infectious diseases has been known before first dose such as hepatitis B, hepatitis C, ect 10. History of neuropathy or mental disorders 11. Pregnant or lactating female 12. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093 13. Known vaccination or hypersensitivity of any level within 4 weeks prior to the first scheduled dose of HS-20093 14. Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator 15. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Anhui Provincial Cancer Hospital Hefei Anhui Recruiting
Fujian Provincial Tumor Hospital Fujian Fujian Not Yet Recruiting
The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army Fuzhou Fujian Recruiting
Guangdong Provincial People's Hospital Guangzhou Guangdong Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
Tumour Hospital of Anyang city Anyang Henan Recruiting
The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan Recruiting
Nanyang Central Hospital Nanyang Henan Recruiting
The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Hubei Cancer Hospital Wuhan Hubei Not Yet Recruiting
Nantong Tumor Hospital Nantong Jiangsu Recruiting
Jiangyin People's Hospital Wuxi Jiangsu Recruiting
Jiangxi Provincial Tumor Hospital Nanchang Jiangxi Not Yet Recruiting
Liaoning Cancer Hospital Shenyang Liaoning Recruiting
The First Hospital of China Medical University Shenyang Liaoning Recruiting
Affiliated Hospital of Jining Medical University Jining Shandong Not Yet Recruiting
Sichuan Cancer Hospital&Institude, Sichuan Cancer Center,Affiliate Cancer Hospital Of University Of Electronic Science and Technology of China Chengdu Sichuan Recruiting
The Affiliated Cancer Hospital of Xinjiang Medical University Ürümqi Xinjiang Recruiting

More Hansoh BioMedical R&D Company trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06112704 on ClinicalTrials.gov ↗ ← All trials in China