An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors

Официальное название

A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors

Обзор

This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.

Вмешательства

• Препарат RPTR-1-201
  RPTR-1-201
• Препарат PD-1 / PD-L1 monoclonal antibody
  PD-1/PD-L1 monoclonal antibody

Первичные конечные точки

• Number of participants with dose-limiting toxicities and treatment-emergent adverse events. [Срок оценки: From first dose through 30 days after last dose of trial treatment.]
• Objective Response Rate (ORR) per RECIST v1.1 [Срок оценки: From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).]

Вторичные конечные точки (7)

• Incidence and severity of adverse events and abnormal safety assessments. [Срок оценки: From first dose through 30 days after last dose of trial treatment]
• Pharmacokinetics of RPTR-1-201 [Срок оценки: First dose until end of treatment (assessed up to 24 months).]
• Progression Free Survival (PFS) [Срок оценки: From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).]
• Overall survival (OS) [Срок оценки: From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).]
• Time to Response [Срок оценки: From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).]
• Pharmacokinetics of RPTR-1-201 (AUC) [Срок оценки: First dose until end of treatment (assessed up to 24 months)]
• Immunogenicity of RPTR-1-201 [Срок оценки: First dose until end of treatment (assessed up to 24 months)]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment.
• At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function as defined in the trial protocol.
• Ability to provide written informed consent and comply with trial procedures.

Критерии исключения

• History of another malignancy within 3 years before the first dose of trial intervention, with the exception of malignancies considered cured and not expected to require active therapy (for example, certain skin cancers or in situ malignancies) per protocol.
• Known active leptomeningeal disease or uncontrolled central nervous system metastases.
• Active, clinically significant, autoimmune diseases requiring systemic immunosuppressive therapy.
• Prior allogenic organ transplantation
• Clinically significant uncontrolled medical or psychiatric condition, that in the opinion of the investigator, would increase risk or interfere with trial participation.
• Other protocol-defined inclusion and exclusion criteria 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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• START Midwest — Grand Rapids

Идентификаторы

NCT: NCT07293754 · RPTR-1-201-101 · 2025-524010-28-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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