HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors
NCT ID: NCT06112704
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2024-02-06
2026-12-31
Brief Summary
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Detailed Description
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Part 1 (phase IIa) will conducted in participants with relapsed, locally advanced or metastatic esophageal carcinoma and other advanced solid tumor. Subjects will receive one dose levels of HS-20093 intravenously every 3 weeks.
Part 2 (phase IIb) will enroll participants with relapsed, locally advanced or metastatic esophageal squamous cell carcinoma. One dose levels of HS-20093 will be administered as an intravenous (IV) infusion every 3 weeks.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase IIa: Cohort 1
Participants with advanced esophageal squamous cell carcinoma will be administered 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.
Phase IIa: Cohort 2
Participants with advanced esophageal adenocarcinoma and gastroesophageal junction adenocarcinoma will be administered 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.
Phase IIa: Cohort 3
Participants with other advanced solid tumor will be administered 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.
Phase IIb
Participants with advanced esophageal squamous cell carcinoma will be administered 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Hansoh BioMedical R&D Company
INDUSTRY
Responsible Party
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Locations
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Fujian Provincial Tumor Hospital
Fujian, Fujian, China
The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Tumour Hospital of Anyang city
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
Jiangyin People's Hospital
Wuxi, Jiangsu, China
Jiangxi Provincial Tumor Hospital
Nanchang, Jiangxi, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Sichuan Cancer Hospital&Institude, Sichuan Cancer Center,Affiliate Cancer Hospital Of University Of Electronic Science and Technology of China
Chengdu, Sichuan, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Countries
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Central Contacts
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Other Identifiers
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HS-20093-203
Identifier Type: -
Identifier Source: org_study_id