Study of the Safety and Efficacy of DS010 in Patients With Cancer Cachexia

Официальное название

Phase I/II Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of DS010 in Patients With Cancer Cachexia

Обзор

A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia

Вмешательства

• Препарат DS010 injection
  Once every 3 weeks intravenously injection
• Препарат DS010 injection
  Once every 3 weeks intravenously injection
• Препарат DS010 injection
  Once every 3 weeks intravenously injection
• Препарат DS010 injection
  Once every 3 weeks intravenously injection
• Препарат DS010 injection
  Once every 3 weeks intravenously injection
• Препарат DS010 injection
  Once every 3 weeks intravenously injection
• Препарат DS010 injection
  Once every 3 weeks or once every 4 weeks intravenously injection
• Препарат DS010 injection
  Once every 3 weeks or once every 4 weeks intravenously injection
• Препарат DS010 injection
  Once every 3 weeks or once every 4 weeks intravenously injection
• Препарат DS010 injection
  Once every 3 weeks or once every 4 weeks intravenously injection

Первичные конечные точки

• Phase 1: Dose-limiting toxicity (DLT) [Срок оценки: 21 days after the first dose]
• Phase 1: Incidence of adverse events as assessed by CTCAE V6.0 [Срок оценки: Up to 20 weeks]
• Phase 2: Change in body weight from baseline to Week 12 [Срок оценки: Baseline, Week 12]

Вторичные конечные точки (8)

• Maximum Observed Plasma Concentration (Cmax) [Срок оценки: From the first dose to week 12]
• Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb, if applicable) [Срок оценки: From the first dose to week 12]
• Serum concentrations of total GDF-15 [Срок оценки: Baseline, week 12]
• Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline [Срок оценки: Baseline, week 12]
• Functional Assessment of Anorexia/Cachexia Therapy (FAACT) total score and subscale scores from baseline [Срок оценки: Baseline, week 12]
• Changes in Patient Global Impression of Severity (PGI-S) from baseline [Срок оценки: Baseline, week 12]
• Changes in Patient Global Impression of Change (PGI-C) from baseline [Срок оценки: Baseline, week 12]
• Changes in appetite visual analogue scale (VAS) score from baseline [Срок оценки: Baseline, week 12]

Критерии участия

Критерии включения

• Subjects aged ≥ 18 years at screening;
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;
• Able to provide written informed consent;
• ECOG performance status score of 0, 1, or 2;
• Patients with histologically or cytologically confirmed malignant solid tumor;
• Cancer cachexia documented in medical records;

Критерии исключения

• History of hypersensitivity or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules composed of monoclonal antibody components;
• Presence of reversible decreased food intake, as determined by the investigator;
• Receiving tube feeding or parenteral nutrition (total or partial parenteral nutrition) at screening;
• Severe gastrointestinal disorders (including esophagitis, gastritis, malabsorption);
• Cachexia caused by other reasons;
• Currently participating in another investigational drug study, or receipt of another investigational product ;

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07530666 · DS010-01-1102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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