TLN-372 in Advanced KRAS Mutant Solid Tumors

Официальное название

An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-372 as a Single Agent and in Combination With Other Anti-Tumor Agents, in Patients With Advanced KRAS Mutant Solid Tumors

Обзор

The primary purpose of this study is to evaluate the safety, pharmacokinetics, and anti-tumor activity of TLN-372 as a single agent and in combination with other anti-tumor agents, in patients with advanced KRAS mutant solid tumors

Вмешательства

• Препарат TLN-372
  Specified dose on specified days
• Препарат TLN-372 in combination with cetuximab
  Specified dose on specified days
• Препарат TLN-372 in combination with pembrolizumab
  Specified dose on specified days

Первичные конечные точки

• Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372 [Срок оценки: Up to 2 years]
• Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation. [Срок оценки: Up to 2 years]
• Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1 [Срок оценки: Up to 2 years]

Вторичные конечные точки (8)

• Maximum observed plasma concentration (Cmax) of TLN-372 [Срок оценки: Up to 2 years]
• Time to peak drug concentration (Tmax) of TLN-372 [Срок оценки: Up to 2 years]
• Minimum observed plasma concentration (Cmin) of TLN-372 [Срок оценки: Up to 2 years]
• Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372 [Срок оценки: Up to 2 years]
• Anti-tumor activity of TLN-372 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression [Срок оценки: Up to 2 years]
• Frequency of dose interruptions, reductions and dose intensity [Срок оценки: Up to 2 years]
• Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 [Срок оценки: Up to 2 years]
• Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Patients must have measurable disease at study entry.
• Patients must have locally advanced or metastatic KRAS mutant solid tumors.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function.

Критерии исключения

• Patients must not have active brain metastases.
• Patients must not have current or past history of central nervous system (CNS) involvement.
• Patients must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
• Patients must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places patients at unacceptable risk of participating in this study.
• Patients must not have clinically significant cardiovascular disease.
• Pregnant or lactating.
• Conditions that could affect drug absorption.

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 · 6 центров

• University of Alabama at Birmingham — Birmingham
• Dana-Farber Cancer Institute — Boston
• START Midwest — Grand Rapids
• Washington University Medical Campus — St Louis
• Memorial Sloan Kettering Cancer Center — New York
• Sarah Cannon Research Institute — Nashville

Австралия · 2 центра

• Peter MacCallum Cancer Centre — Melbourne
• Linear Clinical Research — Perth

Испания · 2 центра

• Hospital Universitary Vall d'Hebron — Barcelona
• START Madrid_Hospital Universitario HM Sanchinarro_CIOCC — Madrid

Канада · 1 центр

• Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT07204340 · TLN-372-2501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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