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

A Phase 2, Open-label, Multi-center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors (ARTEMIS-005)

This study is testing a new treatment called HS-20093 to see if it can help people with advanced esophageal cancer and other solid tumors feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hansoh BioMedical R&D Company (industry)
• Drugs / interventions: chemotherapy
• Locations: 21 sites (Hefei, Anhui and 20 other locations)
• Trial ID: NCT06112704 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced esophageal carcinoma or other solid tumors.

Not a fit: Patients with non-advanced solid tumors or those who have not consented to provide tumor tissue and blood samples may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors, potentially improving their outcomes.

How similar studies have performed: While this approach is novel in targeting B7-H3 with HS-20093, similar antibody-drug conjugates have shown promise in other studies.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 20 other locations

• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (RECRUITING)
• Fujian Provincial Tumor Hospital — Fujian, Fujian, China (NOT_YET_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)
• Nanyang Central Hospital — Nanyang, Henan, China (RECRUITING)
• The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• Hubei Cancer Hospital — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Nantong Tumor Hospital — Nantong, Jiangsu, China (RECRUITING)
• Jiangyin People's Hospital — Wuxi, Jiangsu, China (RECRUITING)
• Jiangxi Provincial Tumor Hospital — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• Liaoning Cancer Hospital — Shenyang, Liaoning, China (RECRUITING)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
• Affiliated Hospital of Jining Medical University — Jining, Shandong, China (NOT_YET_RECRUITING)
• Sichuan Cancer Hospital&Institude, Sichuan Cancer Center,Affiliate Cancer Hospital Of University Of Electronic Science and Technology of China — Chengdu, Sichuan, China (RECRUITING)
• The Affiliated Cancer Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (RECRUITING)

Study contacts

• Study coordinator: Yun Sun

Conditions: Advanced Solid Tumor, Advanced solid tumor, Esophageal Carcinoma, B7-H3, antibody-drug conjugate, HS-20093