A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia

Официальное название

A Phase 1B Dose Escalation Study of AV-380 in Combination With Standard of Care Chemotherapy in Metastatic Cancer Patients With Cachexia and Elevated GDF-15 Levels

Обзор

This open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in cancer patients with Cachexia. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.

Вмешательства

• Биопрепарат AV-380
  AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.

Первичные конечные точки

• Assessment of adverse events (AEs) [Срок оценки: From enrollment to the last follow-up visit approximately 60-days post dose]
• Toxicity [Срок оценки: While receiving study drug (up to 4 months)]
• Laboratory Abnormalities [Срок оценки: From enrollment to the last follow-up visit approximately 60-days post dose.]

Вторичные конечные точки (3)

• Cmax [Срок оценки: From first dose to the last follow-up visit approximately 60-days post dose.]
• Tmax [Срок оценки: From first dose to the last follow-up visit approximately 60-days post dose]
• AUC(0-t) [Срок оценки: From first dose to the last follow-up visit approximately 60-days post dose.]

Критерии участия

Критерии включения

• Patient must be ≥ 18 years of age at the time of signing the informed consent.
• Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.
• Patients with cachexia as defined by Fearon criteria:

• Weight loss > 5% over past 6 months (in absence of simple starvation), or
• BMI < 20 kg/m2 and any degree of weight loss > 2%, or
• Sarcopenia and any degree of weight loss > 2%
• Patients with life expectancy ≥ 3 months

Критерии исключения

• History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody
• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment.
• Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy
• Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• Cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonary disease, heart failure, or HIV/AIDS), or the patient has uncontrolled reversible causes of reduced oral food intake, including, but not limited to, oral mucositis, nausea/vomiting, diarrhea, and/or obstruction, impairing the patient's ability to eat as determined by the Investigator.
• Patients receiving tube feedings or parenteral nutrition at the time of Screening.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 12 центров

• Beverly Hills Cancer Center — Beverly Hills
• Cancer and Blood Specialty Clinic — Lakewood
• Hoag Memorial Hospital — Newport Beach
• Hartford Hospital — Hartford
• Advent Health Orlando Hospital — Orlando
• Nebraska Cancer Specialists — Omaha
• Astera Cancer Care — East Brunswick
• New York Cancer And Blood Specialists — Shirley
• … и ещё 4 центра

Идентификаторы

NCT: NCT05865535 · AV-380-22-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗