A Study in Patients With Advanced Cancers

Официальное название

A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)

Обзор

A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.

Подробное описание

This is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of BIO-106 administered as monotherapy and in combination with pembrolizumab. Phase 1 will define the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BIO-106 that can be advanced to Phase 2. Phase 2 will define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs.

Вмешательства

• Препарат BIO-106
  BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)
• Препарат Pembrolizumab
  Programmed death receptor-1 (PD 1)-blocking antibody

Первичные конечные точки

• Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [Срок оценки: 1 year]
• Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1) [Срок оценки: up to 21 days]
• Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) [Срок оценки: 1 year]
• Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2) [Срок оценки: 2 years]

Вторичные конечные точки (6)

• Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 1) [Срок оценки: 1 year]
• Incidence of adverse event of special interest (AESI) - (Phase 2) [Срок оценки: 2 years]
• Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) [Срок оценки: 2 years]
• PK (Cmax) of BIO-106 - (Phase 1/2) [Срок оценки: 2 years]
• PK (AUC) of BIO-106 - (Phase 1/2) [Срок оценки: 2 years]
• Incidence of anti-BIO-106 antibodies - (Phase 1/2) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Patients histologically or cytologically documented, locally advanced or metastatic solid tumor.
• Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment.
• Measurable disease as determined by RECIST v.1.1 or bone only disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Критерии исключения

• History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody.

Impaired cardiac function or history of clinically significant cardiac disease

• Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
• Active SARS-CoV-2 infection.
• Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.

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 · 3 центра

• NEXT Oncology Austin — Austin
• University of Texas MD Anderson Cancer Center — Houston
• NEXT Oncology Virginia — Fairfax

Идентификаторы

NCT: NCT05320588 · StarBridge-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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