Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors

Официальное название

A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors

Обзор

The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.

Вмешательства

• Препарат EXS74539
  Oral administration

Первичные конечные точки

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to 3 years]
• Number of Participants with Dose-limiting Toxicity (DLT) [Срок оценки: Up to 28 days]
• Number of Participants with Dose Interruptions and Dose Modifications [Срок оценки: Up to 3 years]

Вторичные конечные точки (7)

• Maximum Concentration (Cmax) of EXS74539 [Срок оценки: Cycle 1 Day 25 and at end of treatment (up to approximately 3 years)]
• Time to Cmax (tmax) of EXS74539 [Срок оценки: Cycle 1 Day 25 and at end of treatment (up to approximately 3 years)]
• Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-last]) of EXS74539 [Срок оценки: Cycle 1 Day 1 through end of treatment (up to approximately 3 years)]
• Objective Response Rate (ORR) [Срок оценки: Up to 3 years]
• Duration of Response (DoR) [Срок оценки: Up to 3 years]
• Progression-free Survival (PFS) [Срок оценки: Up to 3 years]
• Overall Survival (OS) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Histologically confirmed diagnosis of the following solid tumors:

• SCLC
• High grade neuroendocrine or small cell carcinomas of non-lung origin
• Non-small cell lung cancer \[NSCLC\]
• Prostate cancer
• Ovarian cancer
• Renal carcinoma \[clear and non-clear cell\]
• Head and neck squamous cell carcinoma
• Hepatic cancer
• Gastric cancer
• Triple-negative breast cancer \[TNBC\]
• Participant disease should have progressed, relapsed or the participants should have been intolerant to at least one prior standard systemic therapy for their respective underlying malignancy.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Критерии исключения

• Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.
• Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Participants with brain metastases must be clinically stable and off corticosteroids and anticonvulsants for ≥1 month prior to study treatment and not require any specific intervention for brain metastases.
• Active and clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy <7 days of the first scheduled dose of the study treatment.
• Significant cardiac abnormalities.
• Major surgery within 28 days prior to the start of study treatment.

Note: Other protocol-defined inclusion and 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

США · 3 центра

• Start Lacn — Los Angeles
• START Dallas — Fort Worth
• START Mountain Region — West Valley City

Идентификаторы

NCT: NCT07517198 · EXS74539-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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