A Study of ERAS-0015 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-0015 Monotherapy and in Combination in Patients Advanced Solid Tumors

Обзор

The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 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-0015 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-0015 monotherapy, followed by dose optimization of ERAS-0015 in combination with other cancer therapies.

Вмешательства

• Препарат ERAS-0015
  ERAS-0015 Administered orally
• Препарат ERAS-0015 in combination
  ERAS-0015 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 65]
• Time to achieve Cmax (Tmax) [Срок оценки: Study Day 1 up to 65]
• Area under the curve [Срок оценки: Study Day 1 up to 65]
• Half-life [Срок оценки: Study Day 1 up to 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), for applicable cohorts.
• 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. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort.
• 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-0015
• 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 · 8 центров

• Providence Medical Group — Santa Rosa
• Florida Cancer Specalists — Sarasota
• Moffitt Cancer Center — Tampa
• Massachusetts General Hospital (MG) — Boston
• Memorial Sloan Kettering Cancer Center — New York
• The University of Texas MD Anderson Cancer Center — Houston
• University of Texas at Tyler — Tyler
• NEXT Virginia — Fairfax

Идентификаторы

NCT: NCT06983743 · ERAS-0015-01 · KEYNOTE-G59 · MK-3475-G59 · 2026-525794-39-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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