ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors

Официальное название

ARTEMIS-101: A Phase 1, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of HS-20093 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors

Обзор

HS-20093 is a fully 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 safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients.

Подробное описание

This is a phase 1, open-label, multi-center, dose-escalation and expansion, phase 1 study in Chinses subjects with advanced solid tumors. This study is in design allowing assessment of safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents.

A total of 5 combination-treatments will be carried out in 3 cohorts. The target population of dose escalation part is patients have progressed on or intolerant to available standard therapies, and the dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.

All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.

Вмешательства

• Препарат HS-20093
  administered as an IV infusion
• Препарат Adebrelimab
  administered as an IV infusion
• Препарат Cisplatin/ Carboplatin
  administered as an IV infusion
• Препарат Cetuximab
  administered as an IV infusion
• Препарат Enzalutamide
  160mg once daily (QD) orally

Первичные конечные точки

• Maximum tolerated dose (MTD) for combination-treatments [Срок оценки: Up to day 21 from the first dose]

Вторичные конечные точки (12)

• Incidence and severity of adverse events (AEs) [Срок оценки: From the first dose through 90 days post end of treatment]
• Objective response rate (ORR) determined by investigators [Срок оценки: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months]
• Disease control rate (DCR) determined by investigators [Срок оценки: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months]
• Duration of response (DoR) determined by investigators [Срок оценки: From the first dose up to PD or death, whichever came first, assessed up to 24 months]
• Progression-free survival (PFS) determined by investigators according to RECIST 1.1 [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 death, whichever came first, assessed up to 24 months]
• Radiographic progression-free survival (rPFS) determined by investigators according to RECIST 1.1 and PCWG3 [Срок оценки: From the first dose up to PD or death from study, whichever came first, assessed up to 24 months]
• Time to PSA progression (TTPP) [Срок оценки: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months]
• Prostate-specific cancer antigen (PSA) response rate [Срок оценки: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months]
• Time to first subsequent therapy (TFST) [Срок оценки: From the first dose up to the imitation of subsequent therapy or death, whichever came first, assessed up to 24 months]
• Observed maximum plasma concentration (Cmax) of HS-20093advanced solid tumor [Срок оценки: From pre-dose to study completion, assessed up to 24 months]
• Time to reach maximum plasma concentration (Tmax) of HS-20093 [Срок оценки: From pre-dose to study completion, assessed up to 24 months]

Критерии участия

Критерии включения

• At least age of 18 years at screening;
• Histologically or cytologically confirmed, locally advanced or metastatic solid tumors

• Dose escalation part will enroll advanced solid tumor for which standard treatment has proven ineffective or unavailable or intolerable.
• Dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
• least one extra-cranial measurable lesion according to RECIST 1
• Agree to provide fresh or archival tumor tissue
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1
• 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 Intolerable for any PD-L1 inhibitor, cetuximab, enzalutamide and cisplatin/ carboplatin 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 Radiotherapy with a limited field of radiation for palliation within 2 weeks, 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
• 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
• Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first scheduled dose of HS-20093
• Subjects with current infectious diseases
• 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
• 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 · 1 центр

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT06332170 · HS-20093-103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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