A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.

Официальное название

A Phase 1 First-in-Human Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-4001 Monotherapy and in Combination in Patients With Advanced Solid Tumors

Обзор

The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain KRAS mutations. ERAS-4001 will be given alone or in combination with other treatments.

Подробное описание

This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-4001 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-4001 monotherapy, followed by dose optimization of ERAS-4001 in combination with other cancer therapies.

Вмешательства

• Препарат ERAS-4001
  ERAS-4001 Administered orally
• Препарат ERAS-4001 in combination
  ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.

Первичные конечные точки

• Dose Limiting Toxicities (DLT) [Срок оценки: Study Day 1 up to Day 21]
• Maximum tolerated dose (MTD) [Срок оценки: Study Day 1 up to Day 21]
• Recommended dose for expansion (RDE) [Срок оценки: Study Day 1 up to Day 21]
• Adverse Events [Срок оценки: Study Day 1 up to Day 21]
• Plasma concentration (Cmax) [Срок оценки: Study Day 1 up to Day 65]
• Time to achieve Cmax (Tmax) [Срок оценки: Study Day 1 up to Day 65]
• Area under the curve [Срок оценки: Study Day 1 up to Day 65]
• Half-life [Срок оценки: Study Day 1 up to Day 65]

Вторичные конечные точки (3)

• Objective Response Rate (ORR) [Срок оценки: Assessed up to 24 months from time of first dose]
• Duration of Response (DOR) [Срок оценки: Assessed up to 24 months from time of first dose]
• Time to Response (TTR) [Срок оценки: Assessed up to 24 months from time of first dose]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Willing and able to give written informed consent
• Pathological documentation of tumor type and mutation prior to the first dose of study drug(s)
• There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy
• Able to swallow oral medication
• Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• Adequate cardiovascular, hematological, liver, and renal function
• Willing to comply with all protocol-required visits, assessments, and procedures

Критерии исключения

• Previous treatment with a RAS inhibitor
• Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-4001
• Received prior palliative radiation within 14 days of Cycle 1, Day 1
• Have primary central nervous system (CNS) tumors
• Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption
• Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs
• Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

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 · 5 центров

• Sarah Cannon Research Institute (SCRI) Oncology Partners — Nashville
• The University of Texas MD Anderson Cancer Center — Houston
• NEXT Oncology — Irving
• NEXT Oncology — San Antonio
• Fred Hutchinson Cancer Center — Seattle

Идентификаторы

NCT: NCT07021898 · ERAS-4001-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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