A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Официальное название

A Dose Escalation and Expansion Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Обзор

The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.

Вмешательства

• Препарат XB371
  Intravenous (IV) infusion.

Первичные конечные точки

• Number of Participants with a Dose-limiting Toxicity (DLT) [Срок оценки: Up to the end of the first cycle (Up to Day 21 of a 21-day cycle)]
• Number of Participants with a Treatment-emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 7 months]

Вторичные конечные точки (8)

• Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan [Срок оценки: Up to approximately 7 months]
• Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan [Срок оценки: Up to approximately 7 months]
• Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan [Срок оценки: Up to approximately 7 months]
• Trough Observed Plasma Concentration (Ctrough) of XB371, Total Antibody and Unconjugated Belotecan [Срок оценки: Up to approximately 7 months]
• Number of Participants with Antidrug Antibodies to XB371 [Срок оценки: Up to approximately 7 months]
• Dose-escalation Cohorts Only: Recommended Dose(s) for Expansion [Срок оценки: Through completion of dose-escalation (up to approximately 18 months)]
• Dose-expansion Cohorts Only: Objective Response Rate as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [Срок оценки: Up to approximately 18 months]
• Dose-expansion Cohorts Only: Duration of Response as Assessed by the Investigator per RECIST v1.1 [Срок оценки: Up to approximately 18 months]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Minimum life expectancy of ≥ 12 weeks.
• Recurrent locally advanced or metastatic solid tumors.
• Adequate end organ and bone marrow function.

Критерии исключения

• Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease.
• History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia.
• Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea.
• Known history of immunodeficiency virus (HIV) unless specific criteria are met.
• Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody.
• Major surgery within 4 weeks before the first dose of study treatment.
• Received radiation therapy within 2 weeks before the first dose of study treatment.
• Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

США · 9 центров

• Exelixis Clinical Site #5 — Rogers
• Exelixis Clinical Site #9 — Los Angeles
• Exelixis Clinical Site #6 — Washington D.C.
• Exelixis Clinical Site #4 — Orlando
• Exelixis Clinical Site #3 — Grand Rapids
• Exelixis Clinical Site #7 — New Brunswick
• Exelixis Clinical Site #2 — Huntersville
• Exelixis Clinical Site #8 — Houston
• … и ещё 1 центр

Идентификаторы

NCT: NCT07123103 · XB371-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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