NCT06112704 HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors
| NCT ID | NCT06112704 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hansoh BioMedical R&D Company |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-02-06 |
| Primary Completion | 2026-07-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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 treatm