Идёт набор NCT07605962

Phase 1/2 Study of UI-102 in Selected Advanced Cancers

Фаза I / Фаза II С лечением Advanced 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: UI-102.
Кому может быть актуально: Состояния в реестре: Advanced 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

A Phase I/II Open-Label, Dose Escalation, Dose Optimization, and Cohort Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of UI-102, a Novel Cholesteryl Pullulan (CHP) Nanoparticle-formulated TLR7/8 Agonist in Patients With Selected Locally Advanced and/or Metastatic Solid Tumors

Обзор

This phase 1/2 first-in-human study is designed to assess the safety and efficacy of UI-102, a TLR7/8 agonist encapsulated in a Cholesteryl Pullulan Nanoparticle.

Подробное описание

This phase 1/2 , open-labelled, multi-center study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary clinical activities of UI-102 in patients with advanced solid tumors. Phase 2 part is designed to assess the efficacy and safety as well as to optimize the dosing amount of UI-102

Вмешательства

Препарат UI-102
Specified dose on specified days

Первичные конечные точки

Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT) [Срок оценки: Up to 24 months]
Dose Escalation: Percentage of participants with ≥1 adverse event (AE) [Срок оценки: Up to 24 months]
Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE) [Срок оценки: Up to 24 months]
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings [Срок оценки: Up to 24 months]
Dose Escalation: Percentage of participants with significant changes in vital signs [Срок оценки: Up to 24 months]
Dose Escalation: Percentage of participants with significant changes in laboratory results [Срок оценки: Up to 24 months]
Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation [Срок оценки: Up to 24 months]
Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1 [Срок оценки: Up to 48 months]

Вторичные конечные точки (7)

Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with Monotherapy and in Combination [Срок оценки: Up to 48 months]
Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with I Monotherapy and in Combination [Срок оценки: Up to 48 months]
Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and in Combination [Срок оценки: Up to 48 months]
Expansion: Duration of Response (DOR) as Determined by RECIST v1.1 with Monotherapy and combination [Срок оценки: Up to 48 months]
Expansion: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and combination [Срок оценки: Up to 48 months]
Plasma Concentration of UI-102 [Срок оценки: Up to 48 months]
Incidence of anti-UI-102 Antibody Formation [Срок оценки: Up to 48 months]

Критерии участия

Критерии включения

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1,
18 Years and Older (adult, older adult),
Histologically confirmed advanced cancer,
Archived or fresh tumor tissue sample that must be confirmed as adequate,
Evaluable/Measurable disease per RECIST 1.1,
Previously received applicable standard treatments,
Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control