A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors

Официальное название

A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors

Обзор

This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.

Подробное описание

This study includes 4 Parts: Part A1 (dose escalation and dose extension for QW administration), Part A2 (dose escalation and dose extension for Q2W administration), Part A3 (dose extension for Q3W administration), and Part B (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with MUC17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).

Вмешательства

• Препарат SSS59
  A humanized antibody targeting MUC17

Первичные конечные точки

• DLTs [Срок оценки: 21 days]
• Safety and tolerability [Срок оценки: during the intervention，Within 28 days of the last dose]
• MTD and RP2D [Срок оценки: through study completion, an average of 2 year]

Вторичные конечные точки (7)

• Cmax of SSS59 [Срок оценки: baseline, during the intervention and at the end of the study]
• Tmax of SSS59 [Срок оценки: baseline, during the intervention and at the end of the study]
• AUC0-last of SSS59 [Срок оценки: baseline, during the intervention and at the end of the study]
• RO of SSS59 [Срок оценки: baseline, during the intervention and at the end of the study]
• Pharmacodynamic (PD) characteristics of SSS59 [Срок оценки: baseline, during the intervention and at the end of the study]
• Immunogenicity of SSS59 [Срок оценки: baseline, during the intervention and at the end of the study]
• Preliminary antitumor activity of SSS59 [Срок оценки: baseline, during the intervention and at the end of the study]

Критерии участия

Критерии включения

• Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Expected survival >3 months.
• Signed informed consent form.
• Must have adequate organ function.

Критерии исключения

• Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss and fatigue.
• Pregnant or nursing women or women/men who are ready to give birth.
• symptomatic central nervous system metastasis.
• Allergy to other antibody drugs or any excipients in the study drugs.
• Underwent major surgery within 4 weeks prior to first dosing.
• The patient is participating in another clinical study, unless it is an observational (non-intervention) clinical study or a follow-up period of an intervention study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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

Китай · 1 центр

• Shanghai First People's Hospital — Шанхай

Идентификаторы

NCT: NCT06944444 · SSS59-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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