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Идёт набор NCT06400472

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Фаза I С лечением Ovarian Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms Carcinoma, Non-Small-Cell Lung

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: LY4170156, bevacizumab, carboplatin, Itraconazole.
Кому может быть актуально
Состояния в реестре: Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung. 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, Австралия, Франция, Италия, Япония +2
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 First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

Обзор

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Вмешательства

  • Препарат LY4170156
    Intravenous
  • Препарат bevacizumab
    IV
  • Препарат carboplatin
    IV
  • Препарат Itraconazole
    oral
  • Препарат pembrolizumab
    IV

Первичные конечные точки

  • Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156 [Срок оценки: 1 Cycle (21 days)]
  • Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab [Срок оценки: 1 Cycle (21 days)]
  • Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin [Срок оценки: 1 Cycle (21 days)]
  • Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab [Срок оценки: 1 Cycle (21 days)]
  • Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR) [Срок оценки: Up to Approximately 48 Months or 4 Years]
  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Срок оценки: Up to Approximately 48 Months or 4 Years]
Вторичные конечные точки (12)
  • To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin) [Срок оценки: First 4 Cycles (84 days)]
  • To characterize the PK properties of LY4170156: Cmin with bevacizumab or carboplatin [Срок оценки: First 4 Cycles (Approximately 84 days)]
  • To characterize the PK properties of LY4170156: Cmin with pembrolizumab [Срок оценки: First 4 Cycles (84 days)]
  • To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC) [Срок оценки: First 4 Cycles (84 days)]
  • To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) [Срок оценки: Up to Approximately 48 Months or 4 Years]
  • To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab [Срок оценки: Up to Approximately 48 Months or 4 Years]
  • To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) [Срок оценки: Up to Approximately 48 Months or 4 Years]
  • To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab [Срок оценки: Up to Approximately 48 Months or 4 Years]
  • To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) [Срок оценки: Up to Approximately 48 Months or 4 Years]
  • To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab [Срок оценки: Up to Approximately 48 Months or 4 Years]
  • To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) [Срок оценки: Up to Approximately 48 Months or 4 Years]
  • To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab [Срок оценки: Up to Approximately 48 Months or 4 Years]]

Критерии участия

Критерии включения

  • Have one of the following solid tumor cancers:
  • Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)
  • Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer
  • Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, and TNBC

Критерии исключения

  • Individual with known or suspected uncontrolled central nervous system (CNS) metastases
  • Individual with history of carcinomatous meningitis
  • Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Individual with evidence of corneal keratopathy or history of corneal transplant
  • Any serious unresolved toxicities from prior therapy
  • Significant cardiovascular disease
  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
  • History of pneumonitis/interstitial lung disease
  • Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 9 центров
  • HonorHealth — Scottsdale
  • University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla
  • South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids
  • NYU Langone Health - Long Island — Mineola
  • New York University (NYU) Clinical Cancer Center — New York
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York
  • The Ohio State University (OSU) Wexner Medical Center — Columbus
  • The University of Texas - MD Anderson Cancer Center — Houston
  • … и ещё 1 центр
Франция · 3 центра
  • Centre Leon Berard — Lyon
  • Institut de Cancerologie de l'Ouest - site St-Herblain — Saint-Herblain
  • Oncopole Claudius Regaud — Toulouse
Япония · 3 центра
  • Shizuoka Cancer Center — Shizuoka
  • National Cancer Center Hospital — Tokyo
  • Cancer Institute Hospital of JFCR — Tokyo
Испания · 3 центра
  • Hospital Universitario Vall d'Hebron — Barcelona
  • Hospital Universitario 12 de Octubre — Madrid
  • Hospital Clinico Universitario de Valencia — Valencia
Австралия · 2 центра
  • Cancer Research SA — Adelaide
  • Icon Cancer Centre South Brisbane — QLD
Италия · 2 центра
  • Humanitas San Pio X — Milan
  • Istituto Europeo di Oncologia — Milan
South Korea · 1 центр
  • National Cancer Center — Goyang-si Gyeonggi-do

Идентификаторы

NCT: NCT06400472 · 18863 · 2024-511238-11-00 · J5E-OX-JZXA · LOXO-FRA-24001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗