Набор скоро начнётся NCT07704515

GKL-006Allo Injection in Patients With Advanced Solid Tumors

Фаза I С лечением Solid Tumor Malignancies

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: GKL-006Allo Injection.
Кому может быть актуально: Состояния в реестре: Solid Tumor Malignancies. Базовые параметры: 18 лет — 75 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: 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 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006Allo Injection in Patients With Solid Tumors

Обзор

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of GKL-006Allo Injection in participants with advanced solid tumors.

Подробное описание

This Phase 1 study will evaluate GKL-006Allo Injection in participants with advanced or metastatic solid tumors who have failed or are intolerant to standard therapy.

The study includes single-dose and multiple-dose treatment, with a potential dose-expansion stage to further evaluate selected dose level according to protocol-specified criteria. The single-dose and multiple-dose stages are designed to characterize safety, tolerability, and biological activity across protocol-specified dose levels.

Participants will receive GKL-006Allo Injection according to the study protocol and will undergo scheduled safety monitoring, tumor assessments, pharmacokinetic and pharmacodynamic sampling, and immunogenicity testing during treatment and follow-up.

Вмешательства

Биопрепарат GKL-006Allo Injection
GKL-006Allo Injection is an allogeneic invariant natural killer T (iNKT) cell therapy. It will be administered according to the dose level, dosing schedule, and treatment stage specified in the protocol.

Первичные конечные точки

Number of Participants With Dose-Limiting Toxicities (DLTs) [Срок оценки: From the first dose through the end of the DLT observation period, assessed up to 28 days.]
Incidence and Severity of Adverse Events [Срок оценки: From the first dose of study treatment until 28 days after the pointed dose of study treatment. The safety monitor will be continued until the end of the study, up to 18 months.]

Вторичные конечные точки (12)

Progression-Free Survival (PFS) [Срок оценки: From the first dose of study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 18 months.]
Overall Survival (OS) [Срок оценки: From the first dose of study treatment until death from any cause, assessed up to 18 months.]
Change From Baseline in EORTC QLQ-C30 Scale Scores [Срок оценки: Baseline and scheduled post-baseline assessments, up to 18 months.]
Immunogenicity [Срок оценки: From baseline through protocol-specified immunogenicity sampling time points, assessed up to 180 days.]
Disease Control Rate (DCR) [Срок оценки: From the first dose of study treatment through scheduled tumor assessments, assessed up to 18 months.]
Objective Response Rate (ORR) [Срок оценки: From the first dose of study treatment through scheduled tumor assessments, assessed up to 18 months.]
Pharmacokinetic characterization of maximum observed plasma concentration (Cmax) [Срок оценки: From 60 minutes before the first dose through 150 days.]
Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax) [Срок оценки: From 60 minutes before the first dose through 150 days.]
Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC) [Срок оценки: From 60 minutes before the first dose through 150 days.]
Pharmacokinetic characterization of terminal elimination half-life (t½) [Срок оценки: From 60 minutes before the first dose through 150 days.]
Pharmacodynamic Biomarkers of NK cells [Срок оценки: From 60 minutes before the first dose through 150 days.]
Pharmacodynamic Biomarkers of Peripheral blood TNF-α [Срок оценки: From 60 minutes before the first dose through 150 days.]

Критерии участия

Критерии включения

Able to understand and voluntarily sign the informed consent form.
Aged 18 to 75 years.
Histologically, cytologically or clinical confirmed unresectable locally advanced or metastatic solid tumor that has failed standard therapy.
At least one measurable tumor lesion during screening according to RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and life expectancy of at least 3 months.
Adequate hematologic and organ function.
Participants of childbearing potential must agree to use at least one medically accepted contraceptive method during study treatment and for 6 months after the end of study treatment.
Able to communicate with the investigator, comply with study visits, and understand and follow study requirements.