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Набор скоро начнётся NCT07416552

A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)

Фаза I С лечением Metastatic Colorectal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SPLIT Abs, 203Pb-DOTAM, 212Pb-DOTAM.
Кому может быть актуально
Состояния в реестре: Metastatic Colorectal Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase I, Open-Label, Escalation and Expansion Study to Evaluate Dosimetry, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CEA-Pre-Targeted 212Pb Therapy in Participants With Metastatic Colorectal Cancer

Обзор

This study will evaluate the dosimetry, safety, efficacy, pharmacokinetics (PK), pharmacodynamics and immunogenicity of CEA-PRIT 2.0 in participants with metastatic microsatellite-stable (MSS) mCRC who are intolerant to or have progressed after having received available standard-of-care (SOC) therapies.

Вмешательства

  • Препарат SPLIT Abs
    Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
  • Препарат 203Pb-DOTAM
    Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
  • Препарат 212Pb-DOTAM
    Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.

Первичные конечные точки

  • Part 1: Serum Concentration of SPLIT Abs [Срок оценки: Up to approximately 48 weeks]
  • Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 3: Percentage of Participants With Adverse Events (AE) [Срок оценки: Up to approximately 5 years]
Вторичные конечные точки (11)
  • Part 1 to 2: Uptake of 203Pb-DOTAM in Tumor and Normal Tissue [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 2: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 3: Serum Concentration of CEA-PRIT 2.0 [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 3: Time Course of Blood and Plasma Radioactivity for 212Pb-DOTAM [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 3: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against SPLIT Abs [Срок оценки: Baseline, Up to approximately 48 weeks]
  • Part 1 to 3: Objective Response Rate (ORR) [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 3: Disease Control Rate (DCR) [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 3: Duration of Response (DOR) [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 3: Progression-Free Survival (PFS) [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 3: Overall Survival (OS) [Срок оценки: Up to approximately 48 weeks]
  • Part 1 to 3: Correlation Between Carcinoembryogenic Antigen (CEA) Tumor Expression and Clinical Activity [Срок оценки: Up to approximately 48 weeks]

Критерии участия

Критерии включения

  • Histologically confirmed adenocarcinoma originating from the colon or rectum
  • Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7)
  • Confirmed MSS and/or proficient mismatch repair (MMR) status
  • Experienced disease progression during or within 3 months following the last administration of systemic anti-cancer therapies for metastatic disease
  • Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Life expectancy estimated by the Investigator to be >=12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  • Adequate cardiovascular, hematological and renal function and laboratory parameters

Критерии исключения

  • Pregnant or breastfeeding or intending to become pregnant
  • Participants with active central nervous system (CNS) metastases
  • History of malignancy other than the one under investigation
  • Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted therapy or surgical procedure
  • Major surgery or significant traumatic injury <4 weeks prior to the first CEA-PRIT 2.0 administration (excluding biopsies) or anticipation of the need for major surgery during study treatment
  • Participants have a known confirmed positive test for HIV
  • Positive hepatitis B surface antigen (HBsAg) test, and/or positive total hepatitis B core Ab (HBcAb) test at screening.
  • Positive hepatitis C (HCV) Ab test result at screening
  • Any anticancer treatment or any investigational agent within 4 weeks (or 5 times the half-life, whichever is shorter) prior to C1D1
  • Prior treatment with a CEA-targeted agent or systemic radio therapy

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 · 1 центр
  • Nebraska Cancer Specialists — Omaha

Идентификаторы

NCT: NCT07416552 · BP45930 · 2025-523322-40-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗