Идёт набор NCT05584800

Study of ZGGS18 in Patients With Advanced Solid Tumors

Фаза I / Фаза II С лечением Advanced Solid 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: ZGGS18 for Injection, ZGGS18 for Injection.
Кому может быть актуально: Состояния в реестре: Advanced Solid Tumor. 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 I/II Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors

Обзор

A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors

Вмешательства

Биопрепарат ZGGS18 for Injection
0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kgof ZGGS18，intravenous infusion, once every 2 weeks.
Биопрепарат ZGGS18 for Injection
Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks.

Первичные конечные точки

Tolerability of ZGGS18 [Срок оценки: 28 days]
Safety of ZGGS18 [Срок оценки: Through study completion, an expected average of 3 years]

Вторичные конечные точки (12)

Pharmacokinetic characteristics of ZGGS18 [Срок оценки: Through Phase I study completion, an expected average of 1 year]
Pharmacokinetic characteristics of ZGGS18 [Срок оценки: Through Phase I study completion, an expected average of 1 year]
Pharmacokinetic characteristics of ZGGS18 [Срок оценки: Through Phase I study completion, an expected average of 1 year]
Pharmacokinetic characteristics of ZGGS18 [Срок оценки: Through Phase I study completion, an expected average of 1 year]
Pharmacokinetic characteristics of ZGGS18 [Срок оценки: Through Phase I study completion, an expected average of 1 year]
Pharmacokinetic characteristics of ZGGS18 [Срок оценки: Through Phase I study completion, an expected average of 1 year]
Immunogenicity of ZGGS18 [Срок оценки: Through study completion, an expected average of 3 years]
Efficacy of ZGGS18 [Срок оценки: Through study completion, an expected average of 3 years]
Efficacy of ZGGS18 [Срок оценки: Through study completion, an expected average of 3 years]
Efficacy of ZGGS18 [Срок оценки: Through study completion, an expected average of 3 years]
Efficacy of ZGGS18 [Срок оценки: Through study completion, an expected average of 3 years]
Efficacy of ZGGS18 [Срок оценки: Through study completion, an expected average of 3 years]

Критерии участия

Критерии включения

Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Life expectancy ≥ 3 months;
Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.