Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

Официальное название

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma

Обзор

The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).

Подробное описание

This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: dose escalation, and dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC and other solid tumors. All eligible subjects will have relapsed or refractory disease after standard therapy.

Вмешательства

• Биопрепарат XmAb819
  Monoclonal Bispecific Antibody

Первичные конечные точки

• Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819) [Срок оценки: 28 days]
• Incidence of dose limiting toxicities (DLTs) [Срок оценки: 28 days]

Вторичные конечные точки (5)

• Measurement of Cmax [Срок оценки: 56 days]
• Measurement of AUCtau [Срок оценки: 56 days]
• Objective Response rate [Срок оценки: 42 days]
• Progression-free survival [Срок оценки: 42 days]
• Duration of response [Срок оценки: 42 days]

Критерии участия

Критерии включения

• Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Subjects who have relapsed and refractory ccRCC, pRCC, NSCLC, and CRC with evidence of disease progression on standard-of-care therapies
• ECOG performance status of 0 or 1.
• All subjects must have adequate tumor sample available (slides or archival FFPE blocks)

Критерии исключения

• Prior treatment with an investigational anti-ENPP3/CD203c therapy
• History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
• Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
• Failure to recover from any clinically significant toxicity related to previous anticancer treatment
• Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
• Active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)
• Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug
• Have a known additional malignancy that is progressing or has required active treatment within the past 2 years

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 · 20 центров

• Xencor Investigative Site — Phoenix
• Xencor Investigative Site — Duarte
• Xencor Investigative Site — Sacramento
• Xencor Investigative Site — New Haven
• Xencor Investigative Site — Jacksonville
• Xencor Investigative Site — Atlanta
• Xencor Investigative Site — Chicago
• Xencor Investigative Site — Chicago
• … и ещё 12 центров

Франция · 2 центра

• Xencor Investigative Site — Bourdeaux
• Xencor Investigative Site — Villejuif

Испания · 2 центра

• Xencor Investigative Site — Barcelona
• Xencor Investigative Site — Madrid

Бельгия · 1 центр

• Xencor Investigative Site — Leuven

Великобритания · 1 центр

• Xencor Investigative Site — Cambridge

Идентификаторы

NCT: NCT05433142 · XmAb819-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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