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Набор скоро начнётся NCT07650357

A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)

Фаза I С лечением Advanced Solid Tumor Non Small Cell Lung Cancer Pancreatic Carcinoma Colorectal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CLSP-5282.
Кому может быть актуально
Состояния в реестре: Advanced Solid Tumor, Non Small Cell Lung Cancer, Pancreatic Carcinoma, Colorectal Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

SENTINEL-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors That Harbor the KRas G12V Mutation

Обзор

Phase 1, open-label, multicenter study to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP 5282 when administered to HLA A\*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.

Подробное описание

CLSP-5282-101 is a Phase 1, open-label, multicenter study designed to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP-5282 when administered to HLA A\*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.

The study will be conducted in 2 parts:

Part A Monotherapy Dose Escalation to determine the MTD and/or RDE(s) to characterize safety and clinical activity of CLSP-5282.

Part B Monotherapy Expansion to explore the preliminary antitumor activity and further characterize the safety, tolerability, PK, and PD of CLSP-5282 at the RDE(s). Part B will include three indication-specific cohorts in pancreatic adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung carcinoma (NSCLC) as well as an all-other solid tumor cohort.

Вмешательства

  • Препарат CLSP-5282
    CLSP-5282 to be administered by IV infusion

Первичные конечные точки

  • Part A Monotherapy Dose Escalation [Срок оценки: 28 days after infusion]
  • Part B Monotherapy Expansion [Срок оценки: Up to 24 months after infusion]
Вторичные конечные точки (12)
  • Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0 [Срок оценки: Up to 30 days after last infusion]
  • Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0 [Срок оценки: Up to 30 days after last infusion]
  • Determine Maximum Plasma Concentration of CLSP-5282 [Срок оценки: Pre-dose and up to 168 hours post-dose]
  • Half-life (t1/2) of CLSP-5282 [Срок оценки: Pre-dose and up to 168 hours post-dose]
  • Assess the immunogenicity of CLSP-5282 [Срок оценки: Up to 24 months after infusion]
  • Part A: Objective Response Rate (ORR) [Срок оценки: Up to 24 months after infusion]
  • Duration of response (DOR) [Срок оценки: Up to 24 months after infusion]
  • Time to Response [Срок оценки: Up to 24 months after infusion]
  • Disease Control Rate [Срок оценки: Up to 24 months after infusion]
  • Progression-free survival (PFS) [Срок оценки: Up to 24 months after infusion]
  • Time on Treatment [Срок оценки: Up to 24 months after infusion]
  • Overall Survival (OS) [Срок оценки: Up to 24 months after infusion]

Критерии участия

Критерии включения

  • Adults at least 18 years of age on the day of signing informed consent.
  • Willing and able to provide written informed consent for the study.
  • Histologically or cytologically diagnosed, locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists.
  • Tumors must harbor the KRas G12V mutation confirmed by the site's local or preferred tissue or ctDNA testing platform in an accredited laboratory.
  • Patients must be HLA-A\*03:01 positive by central assay.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Adequate hematological, renal and hepatic function.
  • Per Investigator judgement, patient is willing and able to complete study visits and/or procedures per the protocol and comply with study requirements for study participation.

Критерии исключения

  • Patients who have received other KRas G12V directed cellular therapies or TCEs.
  • Patients may not be on other anticancer therapies at the time of the first dose of CLSP-5282. Exceptions upon agreement with Sponsor.
  • Any other primary malignancy within the 2 years prior to first dose of study treatment except for non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, breast), or prostate cancer in remission.
  • Patients who have not fully recovered from adverse events due to previous anticancer therapies
  • Patients with active infection requiring systemic antimicrobial therapy
  • Known primary malignant brain tumors, active central nervous system metastases and/or carcinomatous meningitis

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

США · 4 центра
  • Duke Cancer Institute — Durham
  • Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia
  • Sarah Cannon Research Institute (SCRI) Oncology Partners — Nashville
  • Mary Crowley Cancer Research — Dallas

Идентификаторы

NCT: NCT07650357 · CLSP-5282-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗