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)
Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. — From the first dose up to disease progression(PD)or withdrawal from study,whichever comes first,assessed 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 RECIST version 1.1\[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].
Trial sites (21)
Facility
City
Region
Status
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
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.
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