Clinical trial NCT06112704: HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Solid Tumor
Keywords: Advanced solid tumor
Esophageal Carcinoma
B7-H3
antibody-drug conjugate (ADC)
HS-20093
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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 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.

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

Primary outcomes:
measure: Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
timeFrame: From the first dose up to disease progression（PD）or withdrawal from study，whichever comes first，assessed up to 24 months.
Secondary outcomes:
measure: DOR assessed by RECIST 1.1 criteria
timeFrame: From the first dose up to PD or death, whichever came first, assessed up to 24 months.
measure: Disease Control Rate (DCR) assessed by RECIST 1.1 criteria
timeFrame: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months.
measure: PFS assessed by RECIST 1.1 criteria
timeFrame: From the first dose up to PD or death，whichever came first, assessed up to 24 months.
measure: Overall survival (OS)
timeFrame: From the first dose up to PD or death，whichever came first, assessed up to 24 months.
measure: Incidence and severity of adverse events
timeFrame: From the first dose until 90 days after the last dose
measure: Characterize the pharmacokinetic parameters of HS-20093
timeFrame: Cycle 1 Day 1 up to 90 days after the last dose
measure: Assess the incidence of anti-drug antibodies (ADAs)
timeFrame: Cycle 1 Day 1 up to 90 days after the last dose
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Fujian
country: China
facility: Fujian Provincial Tumor Hospital
state: Fujian
city: Fuzhou
country: China
facility: The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Tumour Hospital of Anyang city
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
state: Henan
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Jiangyin People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Tumor Hospital
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Chengdu
country: China
facility: Sichuan Cancer Hospital&Institude, Sichuan Cancer Center,Affiliate Cancer Hospital Of University Of Electronic Science and Technology of China
state: Sichuan
city: Ürümqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References: