A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors

Официальное название

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BGC515 Capsules in Patients With Advanced Solid Tumors

Обзор

The goal of this open-label, dose escalation and dose expansion Phase I clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGC515 administered once daily in 3 weeks cycles in solid tumor patients.

Вмешательства

• Препарат BGC515
  Capsules for oral administration

Первичные конечные точки

• Incidence of adverse events (AEs) and serious adverse events (SAEs). [Срок оценки: Through study completion, approximately 1 year.]
• Dose-limiting toxicities (DLTs) [Срок оценки: Within 24 days after the first dose of study drug.]
• Objective response rate (ORR) [Срок оценки: Through study completion, approximately 3 years.]
• Progress-free survival(PFS) [Срок оценки: Through study completion, approximately 3 years.]

Вторичные конечные точки (4)

• Peak concentration (Cmax). [Срок оценки: Multiple time points, up to approximately 1 year.]
• Time to peak concentration (Tmax). [Срок оценки: Multiple time points, up to approximately 1 year.]
• Half-life (t1/2). [Срок оценки: Multiple time points, up to approximately 1 year.]
• Area under the concentration-time curve from time zero to the last detectable plasma concentration (AUC0-t). [Срок оценки: Multiple time points, up to approximately 1 year.]

Критерии участия

Критерии включения

• Having signed the written Informed Consent Form
• Male or female aged ≥18 years
• Life expectancy ≥12 weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1
• Dose escalation phase: Histologically or cytologically confirmed locally advanced or metastatic mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors who have experienced progressive disease or treatment intolerability after receiving the standard-of-care, or refuse to receive or have no access to the standard-of-care
• Dose expansion phase: Histologically or cytologically confirmed locally advanced or metastatic MM, EHE, etc. regardless of Hippo signaling pathway abnormalities, or other advanced solid tumors with Hippo signaling pathway abnormalities, who have experienced progressive disease or treatment intolerability after receiving the standard-of-care, or refuse to receive or have no access to the standard-of-care
• At least one measurable lesion

Критерии исключения

• Previous or current use of transcriptional enhanced associate domain (TEAD) inhibitors
• Inadequate wash-out of prior therapies described per protocol
• Patients with severe or unstable systemic disease, unstable or symptomatic Central Nervous System (CNS) metastasis
• Clinically significant cardiovascular disease as defined in the protocol
• Women who are pregnant or breastfeeding
• Hypersensitivity to the active pharmaceutical ingredient or any excipient of BGC515
• Study staff member or relative of a study staff member directly related to this clinical trial, or a subordinate of the Investigator in this trial or an employee of the Sponsor, though not directly related to this trial
• Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical 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 · 1 центр

• MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06452160 · BGC515-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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