A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer

Официальное название

A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients With Small Cell Lung Cancer

Обзор

This is a multi-center, open-label, Phase 1 clinical study of ZG006 in the US for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. During the dose escalation stage, a standard "3+3" design will be used to assess the MTD/ recommended dose for the subsequent studies.

Вмешательства

• Препарат ZG006
  ZG006 will be administered as an intravenous (IV) infusion.

Первичные конечные точки

• The incidence of dose-limiting toxicity (DLT) [Срок оценки: Up to 28 days]
• Maximum Tolerated Dose (MTD) of ZG006 [Срок оценки: Approximately 2 years]
• Determine the Recommended Phase 2 Dose (RP2D) [Срок оценки: Approximately 2 years]
• Number of participants with adverse events (AEs) [Срок оценки: Approximately 2 years]
• Number of participants with serious adverse events (SAEs) [Срок оценки: Approximately 2 years]
• Incidence of abnormal laboratory results [Срок оценки: Approximately 2 years]

Вторичные конечные точки (8)

• Objective response rate (ORR) [Срок оценки: Approximately 2 years]
• Duration of response (DOR) [Срок оценки: Approximately 2 years]
• Disease control rate (DCR) [Срок оценки: Approximately 2 years]
• Maximum plasma concentration (Cmax) of ZG006 [Срок оценки: Approximately 2 years]
• Time to peak concentration (Tmax) [Срок оценки: Approximately 2 years]
• AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of ZG006 [Срок оценки: Approximately 2 years]
• Terminal phase half-life (t1/2) of ZG006 [Срок оценки: Approximately 2 years]
• Detection of anti-drug antibodies (ADA) [Срок оценки: Approximately 2 years]

Критерии участия

Критерии включения

• Small cell lung cancer (SCLC), who failed or intolerant to available standard treatments;
• Tissue sample positive for DLL3 expression;
• Life expectancy ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.

Критерии исключения

• Patients having received any of the following treatments:

• Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry;
• Systemic immunosuppressive medications, such as corticosteroid (doses \> 10 mg/day prednisone or equivalent dose) within 14 days prior to the study entry;
• Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;
• Patients received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry;
• A history of severe, life-threatening immune-mediated adverse events or infusion-related reactions during previous anti-tumor immunotherapy, including events that led to permanent discontinuation of treatment;
• Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B/C, active syphilis, or active human immunodeficiency virus infection);
• Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins;
• A female who is pregnant or nursing;
• Patients were deemed unsuitable for participating in the study by the investigator for any reason.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Zelgen Site 105 — Orange
• Zelgen Site 102 — Plantation
• Zelgen Site 103 — Lexington
• Zelgen Site 101 — Canton
• Zelgen Site 104 — Cleveland
• Zelgen Site 106 — Houston

Идентификаторы

NCT: NCT06592638 · ZG006US001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗