Status:
RECRUITING
HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-t...
Detailed 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...
Eligibility Criteria
Inclusion
- Men or women aged more than or equal to (≥) 18 years.
- Histologically or cytologically confirmed, relapsed, locally advanced or metastatic esophageal carcinomas and other advanced solid tumor.
- At least one extra measurable lesion according to RECIST 1.1 (cavity structures such as oesophagus cannot serve as measurable lesions).
- Agree to provide fresh or archival tumor tissue and blood samples.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.
- Estimated life expectancy \>12 weeks.
- Agree to use medically accepted methods of contraception.
- Men or women should be using adequate contraceptive measures throughout the study.
- Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
- Signed and dated Informed Consent Form.
Exclusion
- Any of the following would exclude the subject from participation in the study:
- 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
- Subjects with previous or concurrent malignancies
- Significant tumor invasion into adjacent organs (aorta or trachea) of esophageal lesions leading to higher risk of bleeding or fistula
- Inadequate bone marrow reserve or organ dysfunction.
- Evidence of cardiovascular risk
- Evidence of current severe or uncontrolled systemic diseases
- Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
- Severe infections occured within 4 weeks before the first dose
- The presence of active infectious diseases has been known before first dose such as hepatitis B, hepatitis C, ect
- History of neuropathy or mental disorders
- Pregnant or lactating female
- 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
- Known vaccination or hypersensitivity of any level within 4 weeks prior to the first scheduled dose of HS-20093
- Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator
- Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments
Key Trial Info
Start Date :
February 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06112704
Start Date
February 6 2024
End Date
December 31 2026
Last Update
December 2 2024
Active Locations (21)
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1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230031
2
Fujian Provincial Tumor Hospital
Fujian, Fujian, China, 350014
3
The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Fuzhou, Fujian, China, 350014
4
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000