Идёт набор NCT06885281

A Study of ZL-1310 in Participants With Selected Solid Tumors

Фаза I / Фаза II С лечением Solid Tumors

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: ZL-1310.
Кому может быть актуально: Состояния в реестре: Solid Tumors. 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 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors

Обзор

A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors

Подробное описание

This is an open-label, multiple-center, phase 1b/2 study of ZL-1310 in selected solid tumors. ZL-1310 will be administered intravenously at 1.6 mg/kg every 21 days. Primary objectives include safety evaluation and confirmed objective response rate by blinded independent central review

Вмешательства

Препарат ZL-1310
drug ZL-1310

Первичные конечные точки

Incidence of Treatment Emergent Adverse-Events in Phase 1b [Срок оценки: up to 36 months]
Incidence of Serious Adverse Events in Phase 1b [Срок оценки: up to 36 months]
Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2 [Срок оценки: up to 36 months]

Вторичные конечные точки (12)

Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 1b [Срок оценки: up to 36 months]
Evaluate durability of response in Phase 1b [Срок оценки: up to 36 months]
Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 2 [Срок оценки: up to 36 months]
Evaluate durability of response in Phase 2 [Срок оценки: up to 36 months]
Incidence of Treatment Emergent Adverse-Events in Phase 2 [Срок оценки: up to 36 months]
Incidence of Serious Adverse Events in Phase 2 [Срок оценки: up to 36 months]
Pharmacokinetics (PK): Time to maximum concentration (Tmax) of Total Antibody in all phases [Срок оценки: up to 36 months]
Pharmacokinetics (PK): maximum concentration (Cmax) of Total Antibody in all phases [Срок оценки: up to 36 months]
Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Total Antibody in all phases [Срок оценки: up to 36 months]
Pharmacokinetics (PK): apparent clearance (CL) of Total Antibody in all phases [Срок оценки: up to 36 months]
Pharmacokinetics (PK): terminal elimination half-life (T1/2) of Total Antibody in all phases [Срок оценки: up to 36 months]
Pharmacokinetics (PK): time to maximum concentration (Tmax) of Unconjugated payloads in all phases [Срок оценки: up to 36 months]

Критерии участия

Критерии включения

Signed informed consent
Adult men and women ≥18 years of age
Participants must have histologically confirmed, locally advanced or metastatic NeuroEndocrine Carcionomas (NEC)
Participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample
Participants must have at least one measurable target lesion as defined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy ≥ 3 months

Критерии исключения

Participants with another known malignancy that is progressing or requires active treatment within the last 2 years
Clinically active central nervous system (CNS) metastases
Participants with leptomeningeal metastasis
Participants who have received any ADC with a payload of topoisomerase I inhibitor (e.g., exatecan derivative)or had received topoisomerase I inhibitor (e.g., irinotecan) as the immediate prior therapy that the participant had progressed from.
Treatment with any systemic anti-cancer treatment or other investigational products/device within 3 weeks before the first dose of study treatment
Non-palliative radiotherapy within 2 weeks to non-thoracic area or within 4 weeks to the thoracic area prior to first dose of study treatment or a history of radiation pneumonitis
Major surgery within 4 weeks of the first dose of study treatment
Hypersensitivity to any ingredient of the study treatment
Out of range value (as defined in protocol) within 10 days prior to the first dose of study treatment
Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders including but not limited to pneumonitis
Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
Pregnant or nursing (lactating) women
Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer

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

Здоровые добровольцы: Нет