Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC

Официальное название

A Phase I Multicentre Open-label Study to Evaluate Safety, Tolerability, and Dosimetry of [111In]-FPI-2107 in Chinese Adult Participants With EGFR Mutation-positive NSCLC

Обзор

This is a Phase I, multicentre, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, PD, and PK of \[111In\]-FPI-2107 after pre-dose administration of FPI-2053 in Chinese participants with EGFR mutation-positive NSCLC.

Вмешательства

• Препарат [111In]-FPI-2107
  radioimmuno-SPECT agent
• Препарат FPI-2053
  unconjugated/unlabelled bispecific antibody \[cold\]

Первичные конечные точки

• Safety and tolerability of [111In]-FPI 2107 following the administration of FPI 2053 [Срок оценки: From the screening period to 21 days after dosing]
• Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053 [Срок оценки: During the Imaging period (Day1 - Day4/5)]
• Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053 [Срок оценки: During the Imaging period (Day1 - Day4/5)]

Вторичные конечные точки (5)

• Tumour uptake of [111In]-FPI-2107 [Срок оценки: During the Imaging period (Day1 - Day4/5)]
• PK of [111In]-FPI-2107: Peak Plasma Concentration (Cmax) [Срок оценки: From the dose of investigation product (Day 1) until Day 4/5]
• PK of [111In]-FPI-2107: AUClast [Срок оценки: From the dose of investigation product (Day 1) until Day 4/5]
• PK of [111In]-FPI-2107: Clearance [Срок оценки: From the dose of investigation product (Day 1) until Day 4/5]
• PK of [111In]-FPI-2107: Half-life [Срок оценки: From the dose of investigation product (Day 1) until Day 4/5]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed EGFR mutation positive NSCLC.
• Without any ongoing anti-cancer therapy or with stable ongoing anti-cancer therapy.
• At least one lesion that is present on 18F-FDG PET/CT scan during screening.
• ECOG performance status of 0 or 1.
• Anticipated life expectancy ≥ 12 weeks, in the opinion of the Investigator.
• Able to provide tumour tissue for analysis.

Критерии исключения

• Confirmed radiographic disease progression or Investigator-assessed clinical disease progression within 28 days prior to the administration of \[111In\]-FPI-2107.
• Contraindications to or inability to perform the imaging procedures required in this study.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month).
• History of myocardial infarction or New York Heart Association Class II-IV congestive heart failure within 6 months of the administration of \[111In\]-FPI-2107, CTCAE Grade 2 or worse conduction defect or uncontrolled hypertension.
• Clinically relevant proteinuria, or daily urinary protein excretion > 500 mg).
• Any antibody-based therapy targeting EGFR and/or c-MET, or investigational agent within 28 days or 5 half-lives prior to the administration of \[111In\]-FPI-2107, whichever is shorter.
• Any systemic radiopharmaceutical within 28 days or 5 radioactive half-lives prior to the administration of \[111In\]-FPI-2107, whichever is shorter.
• Any anticipated need for switching of any concomitant anti-cancer therapy during the imaging period of the study.
• External beam radiation therapy within 28 days prior to the administration of \[111In\]-FPI-2107.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 3 центра

• Research Site — Пекин
• Research Site — Shandong
• Research Site — Ухань

Идентификаторы

NCT: NCT07500987 · D8650C00002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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