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Идёт набор NCT07456046

A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.

Фаза I С лечением KRAS P.G12D

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: D3S-003.
Кому может быть актуально
Состояния в реестре: KRAS P.G12D. 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, South Korea
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 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-003 Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation

Обзор

This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants with advanced KRAS p.G12D mutant solid tumors.

Вмешательства

  • Препарат D3S-003
    Oral Tablet

Первичные конечные точки

  • Number of Participants with Dose-Limiting Toxicities (DLTs) [Срок оценки: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.]
  • Number of Participants with Adverse Events (AEs) [Срок оценки: From screening visit until 30 days after the last dose (or specified in the protocol)]
  • Maximum tolerated dose (MTD) based on dose limiting toxicities (DLTs) [Срок оценки: First dose up to 7 months]
  • Phase 2 dose (RP2D) [Срок оценки: First dose up to 7 months]
Вторичные конечные точки (9)
  • D3S-003 concentration of drug immediately before the administration of next dose (Ctrough) [Срок оценки: First dose up to 7 months]
  • D3S-003 maximum observed plasma concentration (Cmax) [Срок оценки: First dose up to 7 months]
  • D3S-003 time to maximum plasma concentration (tmax) [Срок оценки: First dose up to 7 months]
  • D3S-003 half-life (t1/2) [Срок оценки: First dose up to 7 months]
  • D3S-003 area under the concentration-time curve (AUC) [Срок оценки: First dose up to 7 months]
  • Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Срок оценки: Until disease progression or end of treatment (up to approximately 7 months)]
  • Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Срок оценки: Until disease progression or end of treatment (up to approximately 7 months)]
  • Disease Control Rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Срок оценки: Until disease progression or end of treatment (up to approximately 7 months)]
  • Progression-free survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Срок оценки: Until disease progression or end of treatment (up to approximately 7 months)]

Критерии участия

Критерии включения

  • Subjects must have histologically confirmed locally advanced, recurrent, or metastatic malignancy that has progressed following at least one line of standard therapy or where standard therapy has proven to be ineffective or intolerable or is considered inappropriate or when participation in a clinical trial of an investigational agent is considered a standard therapeutic option.
  • Subjects must have documented presence of KRAS p.G12D mutation by a local test identified through tumor tissue or blood collected within the last 5 years.
  • Subjects must have measurable disease per RECIST v1.1.
  • Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject must have adequate organ and marrow function within the screening period.

Критерии исключения

  • Participant has any prior treatment with a specific KRAS G12D inhibitor/degrader or pan RAS inhibitor/degrader.
  • Subject has uncontrolled intercurrent illness, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, ongoing or active infections, uncontrolled or significant cardiovascular disease, autoimmune or inflammatory disorders or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events (AEs), or compromise the ability of the subject to give written consent.
  • Uncontrolled or untreated brain metastases
  • Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy

NOTE: Other protocol inclusion/exclusion criteria may apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Австралия · 3 центра
  • D3 Bio Investigative Site 1101 — Macquarie Park
  • D3 Bio Investigative Site 1103 — Randwick
  • D3 Bio Investigative Site 1102 — Malvern
South Korea · 3 центра
  • D3 Bio Investigative Site 1201 — Seoul
  • D3 Bio Investigative Site 1203 — Seoul
  • D3 Bio Investigative Site 1202 — Seoul
США · 2 центра
  • D3 Bio Investigative Site 1404 — New Haven
  • D3 Bio Investigative Site 1402 — San Antonio

Идентификаторы

NCT: NCT07456046 · D3S-003-100

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗