A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Официальное название

AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Обзор

This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.

Вмешательства

• Препарат ALPS12
  ALPS12 as an IV infusion
• Препарат obinutuzumab
  Obinutuzumab as an IV infusion

Первичные конечные точки

• All part : Adverse events of ALPS12[safety and tolerability] [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Dose Escalation part : Dose-limiting toxicities (DLTs) and PK profile of ALPS12[safety and tolerability] [Срок оценки: From Cycle 1 Day 1 to the administration of ALPS12 on Cycle 2 Day 1 (Cycle 1 is 21 days)]
• Dose Escalation part : Immunogenicity of ALPS12 [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Expansion part : Preliminary anti-tumor activity of ALPS12 when administered at selected dose(s) based on tumor assessment in patients with extensive stage SCLC [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]

Вторичные конечные точки (8)

• Objective response rate(ORR)[preliminary efficacy] [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Disease control [preliminary efficacy] [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Duration of response (DoR)[preliminary efficacy] [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Progression-free survival (PFS)[preliminary efficacy] [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Overall survival (OS)[preliminary efficacy] [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Immunogenicity of obinutuzumab [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Maximum serum concentration (Cmax) and Area under the concentration time-curve (AUC) of ALPS12 with obinutuzumab[PK profile] [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Adverse events of obinutuzumab[safety and tolerability] [Срок оценки: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]

Критерии участия

Критерии включения

• Aged >18 years at time of informed consent
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
• Histologically documented extensive stage small cell lung cancer
• Disease recurrence documented after at least one prior systemic therapy.
• Confirmed availability of representative archival tumor specimens or fresh tumor specimen.
• Measurable disease per RECIST v.1.1.
• Adequate hematologic and end organ function

Критерии исключения

• Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study
• History or complication of clinically significant autoimmune disease
• a positive HIV antibody test at screening
• Active hepatitis B or hepatitis C
• Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and/or DLL3-targeted therapies
• Patients who have received any investigational or approved anticancer therapy, including hormone therapy and/or radiotherapy, within 21 days prior to the first administration of the investigational drug.
• History of Grade 4 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase)
• Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase), and/or patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug
• Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug
• History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease
• Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)

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

Япония · 4 центра

• National Cancer Center Hospital East — Kashiwa
• Ehime University Hospital — Tōon
• Kindai University Hospital — Sakai
• Niigata Cancer Center Hospital — Niigata

Гонконг · 1 центр

• Queen Mary Hospital — Гонконг

Тайвань · 1 центр

• Show Chwan Memorial Hospital — Changhua

Идентификаторы

NCT: NCT07107490 · ALP102CT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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