HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат HS-20093
  Intravenous (IV) infusion of HS-20093 Q3W; Participants will receive continuous treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Первичные конечные точки

• Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. [Срок оценки: From the first dose up to disease progression（PD）or withdrawal from study，whichever comes first，assessed up to 24 months.]

Вторичные конечные точки (7)

• DOR assessed by RECIST 1.1 criteria [Срок оценки: From the first dose up to PD or death, whichever came first, assessed up to 24 months.]
• Disease Control Rate (DCR) assessed by RECIST 1.1 criteria [Срок оценки: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months.]
• PFS assessed by RECIST 1.1 criteria [Срок оценки: From the first dose up to PD or death，whichever came first, assessed up to 24 months.]
• Overall survival (OS) [Срок оценки: From the first dose up to PD or death，whichever came first, assessed up to 24 months.]
• Incidence and severity of adverse events [Срок оценки: From the first dose until 90 days after the last dose]
• Characterize the pharmacokinetic parameters of HS-20093 [Срок оценки: Cycle 1 Day 1 up to 90 days after the last dose]
• Assess the incidence of anti-drug antibodies (ADAs) [Срок оценки: Cycle 1 Day 1 up to 90 days after the last dose]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 21 центр

• Anhui Provincial Cancer Hospital — Хэфэй
• Fujian Provincial Tumor Hospital — Fujian
• The 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation A — Фучжоу
• Guangdong Provincial People's Hospital — Гуанчжоу
• Harbin Medical University Cancer Hospital — Харбин
• Tumour Hospital of Anyang city — Anyang
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang
• Nanyang Central Hospital — Nanyang
• … и ещё 13 центров

Идентификаторы

NCT: NCT06112704 · HS-20093-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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