Идёт набор NCT04192344

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor

Фаза I С лечением Neoplasms Tenosynovial Giant Cell Tumor

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ABSK021.
Кому может быть актуально: Состояния в реестре: Neoplasms, Tenosynovial Giant Cell Tumor. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor

Обзор

This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.

Подробное описание

The study will start with a dose escalation part of single-agent ABSK021 administered in repeated 28-day cycles in patients with advanced solid for safety and tolerability. The expansion part of oral ABSK021 at recommended dose of expansion (RDE) will be followed for further evaluating safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.

Вмешательства

Препарат ABSK021
ABSK021 oral capsule

Первичные конечные точки

Incidence of DLTs [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
Incidence and Severity of AEs [Срок оценки: Through study completion, an average of 6 months]

Вторичные конечные точки (7)

PFS [Срок оценки: From date of enrollment until the date of first documented progression or death, assessed up to 12 months]
DoR [Срок оценки: From date of enrollment until the date of first documented progression or death, assessed up to 12 months]
DCR [Срок оценки: 24 weeks post-dose]
Cmax [Срок оценки: Pre-dose and multiple timepoints (up to 72 hours) post-dose]
tmax [Срок оценки: Pre-dose and multiple timepoints (up to 72 hours) post-dose]
Bioavailability [Срок оценки: Pre-dose and multiple timepoints (up to 72 hours) post-dose]
Elimination half-life [Срок оценки: Pre-dose and multiple timepoints (up to 72 hours) post-dose]

Критерии участия

Критерии включения

Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists
ECOG (electrocorticogram) performance status 0\~1
Life expectancy ≥ 3 months
Adequate organ function and bone marrow function

For patients with tenosynovial giant cell tumor (TGCT) :

A diagnosis of TGCT \[i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);
Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;
Others

Критерии исключения

Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colony stimulating factor 1 receptor) pathway inhibitors
Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment
Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication
Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever is shorter) prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment)
Major surgery within 4 weeks of the first dose of study drug and all surgical wounds must be healed and free of infection or dehiscence
Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤2 severity (CTCAE v5.0) with the exception of alopecia and vitiligo
Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug
Concomitant use of strong inhibitors or inducers of CYP3A4
Active central nervous system (CNS) metastases
Impaired cardiac function or clinically significant cardiac disease
Patients with Gilbert's Syndrome or other underlying conditions that may lead to a greater likelihood of developing LFT(liver function test) abnormalities during the study
Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection
Refractory/uncontrolled ascites or pleural effusion
Pregnant or nursing

For patients with tenosynovial giant cell tumor (TGCT) :

Known allergy or hypersensitivity to any component of the investigational drug product
For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US）
Others

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет