HS-20093 treatment for advanced esophageal cancer and other solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 clinical trial evaluates HS-20093, a humanized antibody-drug conjugate targeting B7-H3, in patients with advanced esophageal carcinoma and other solid tumors. The study is divided into two parts: phase IIa focuses on patients with relapsed or metastatic tumors, while phase IIb specifically targets those with esophageal squamous cell carcinoma. Participants will receive intravenous doses of HS-20093 every three weeks, and the study aims to assess the drug's anti-tumor activity, safety, pharmacokinetics, and immunogenicity.

Why it matters

Who can join: the full rules

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

Where it's running

• Anhui Provincial Cancer Hospital
  Hefei, Anhui, China Recruiting
• The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
  Fuzhou, Fujian, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• Tumour Hospital of Anyang city
  Anyang, Henan, China Recruiting
• The First Affiliated Hospital of Henan University of Science & Technology
  Luoyang, Henan, China Recruiting

Study contacts

• Study coordinator: Yun Sun
• Email: suny20@hspharm.com
• Phone: 18321785381

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.