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

Last updated: November 27, 2024
Sponsor: Hansoh BioMedical R&D Company
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Digestive System Neoplasms

Esophageal Disorders

Treatment

HS-20093

Clinical Study ID

NCT06112704
HS-20093-203
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Men or women aged more than or equal to (≥) 18 years.

  2. Histologically or cytologically confirmed, relapsed, locally advanced or metastaticesophageal carcinomas and other advanced solid tumor.

  3. At least one extra measurable lesion according to RECIST 1.1 (cavity structures suchas 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 ofnon-childbearing potential.

  10. Signed and dated Informed Consent Form.

Exclusion

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 cytotoxicchemotherapy, investigational agents and anticancer drugs within 14 days prior tothe first scheduled dose of HS-20093 Prior treatment with a monoclonal antibodywithin 28 days prior to the first scheduled dose of HS-20093 Local radiotherapy forpalliation within 2 weeks of the first dose of study drug, or patients received morethan 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeksprior to the first scheduled dose of HS-20093 Major surgery within 4 weeks prior tothe first scheduled dose of HS-20093

  2. Subjects with previous or concurrent malignancies

  3. Significant tumor invasion into adjacent organs (aorta or trachea) of esophageallesions 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 scheduleddose 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 ashepatitis 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 oridiosyncrasy to drugs chemically related to HS-20093 or any of the components ofHS-20093

  13. Known vaccination or hypersensitivity of any level within 4 weeks prior to the firstscheduled dose of HS-20093

  14. Unlikely to comply with study procedures, restrictions, and requirements in theopinion of the investigator

  15. Any disease or condition that, in the opinion of the investigator, would compromisesubject safety or interfere with study assessments

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: HS-20093
Phase: 2
Study Start date:
February 06, 2024
Estimated Completion Date:
December 31, 2026

Study Description

This is an open-label, multi-center phase 2 study in Chinese adult participants with recurrent, locally advanced or metastatic esophageal carcinoma or other advanced solid tumors, which is designed to investigate the efficacy, safety, pharmacokinetics and immunogenicity of HS-20093. This study will consist of two parts: phase IIa and phase IIb.

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.

Connect with a study center

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui 230031
    China

    Active - Recruiting

  • Fujian Provincial Tumor Hospital

    Fujian, Fujian 350014
    China

    Site Not Available

  • The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 1540000
    China

    Active - Recruiting

  • Tumour Hospital of Anyang city

    Anyang, Henan 455000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan 471003
    China

    Active - Recruiting

  • Nanyang Central Hospital

    Nanyang, Henan 422000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan 453100
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu 226300
    China

    Active - Recruiting

  • Jiangyin People's Hospital

    Wuxi, Jiangsu 214400
    China

    Active - Recruiting

  • Jiangxi Provincial Tumor Hospital

    Nanchang, Jiangxi 330038
    China

    Site Not Available

  • Liaoning Cancer Hospital

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110002
    China

    Active - Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong 272000
    China

    Site Not Available

  • Sichuan Cancer Hospital&Institude, Sichuan Cancer Center,Affiliate Cancer Hospital Of University Of Electronic Science and Technology of China

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 830011
    China

    Active - Recruiting

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