Идёт набор NCT07374848

Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors

Фаза I С лечением Solid Tumors Sarcomas

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-6201.
Кому может быть актуально: Состояния в реестре: Solid Tumors, Sarcomas. 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

An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants With Sarcoma and Selected Solid Tumors

Обзор

The purpose of this study is to evaluate the safety and tolerability of investigational study drug ZL-6201 for treating sarcoma and solid tumors cancer.

Подробное описание

An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants with Sarcoma and Selected Solid Tumors

Вмешательства

Препарат ZL-6201
ZL-6201 as a single-agent

Первичные конечные точки

Incidence of Dose Limiting Toxicities [Срок оценки: 1 cycle of study treatment (each cycle is 21 days)]
Incidence of Treatment Emergent Adverse Events [Срок оценки: 36 months]
Incidence of Serious adverse events [Срок оценки: 36 months]
Number of participants with clinical laboratory abnormalities [Срок оценки: 36 months]
Number of participants with vital sign abnormalities [Срок оценки: 36 months]
Number of participants with electrocardiogram (ECG) abnormalities [Срок оценки: 36 months]

Вторичные конечные точки (6)

ORR per RECIST 1.1 [Срок оценки: 36 months]
Duration of Response per RECIST 1.1 [Срок оценки: 36 months]
PFS per RECIST 1.1 [Срок оценки: 36 months]
DCR per RECIST 1.1 [Срок оценки: 36 months]
PK characteristics of ZL-6201 (ADC conjugate), total antibody [Срок оценки: 36 months]
PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads [Срок оценки: 36 month]

Критерии участия

Критерии включения

Adult men and women ≥18 years of age at the time of signing the ICF with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy > 3 months
Participants must have histologically confirmed and documented diagnosis of locally advanced unresectable and/or metastatic sarcoma or a selected solid tumor
Participants must be willing to undergo a tumor biopsy prior to start of treatment or provide archived tumor tissue sample
Participants with sarcoma should have received no more than 2 lines of previous systemic therapies in the metastatic setting
Participants with selected epithelial solid tumors should have received no more than 3 lines of previous systemic therapy in the metastatic/relapsed refractory setting
Participants must have at least one measurable target lesion as defined by RECIST v1.1
Adequate organ and marrow function as listed per protocol
Must be negative for HIV, HBV, and HCV

Критерии исключения

Participants with another known malignancy that has required treatment within the last 2 years
Symptomatic central nervous system (CNS) metastasis, and/or those requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
Participants with leptomeningeal metastasis
Most recent systemic anti-cancer treatment or investigational products/devices less than 3 weeks
Prior treatment with a topoisomerase-1 inhibitor antibody drug conjugate
Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
Clinically significant pulmonary disease including autoimmune, connective tissue, or inflammatory conditions
Pregnant or nursing (lactating) women

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

Здоровые добровольцы: Нет