Идёт набор NCT06977737

A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours

Фаза I / Фаза II С лечением Solid Tumor, Adult

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: ATTR-01.
Кому может быть актуально: Состояния в реестре: Solid Tumor, Adult. 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: Испания, Великобритания
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 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants With Select Epithelial Solid Tumours Under Multiple Sub-protocols

Обзор

ATTR-01 is the experimental drug being studied in the ATTEST clinical trial. The drug is made from a common cold virus that has been changed to only infect and multiply in cancer cells. This virus delivers an immune therapy drug into the cancer that is intended to promote a participant's own immune system to attack the cancer. The first part of this trial (sub-protocol A) is a phase 1 trial including dose escalation and expansion at one or more doses. It is the first time that ATTR-01 will be given to humans. If an optimal dose is identified, additional sub-protocols will be added by to further elicit whether ATTR-01 may successfully treat cancer. Expanded access is not available.

Вмешательства

Препарат ATTR-01
Intravenous injection

Первичные конечные точки

• Incidence of treatment emergent adverse events (AEs) [safety and tolerability] [Срок оценки: 1 year, 2 years and 5 years]
• Determination of the optimal dose of ATTR-01 [Срок оценки: 1 year, 2 years and 5 years]
• Objective Response Rate (ORR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] [Срок оценки: 1 year, 2 years and 5 years]
Duration of Response (DoR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] [Срок оценки: 1 year, 2 years and 5 years]

Вторичные конечные точки (8)

Disease Control Rate (DCR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] [Срок оценки: 1 year, 2 years and 5 years]
Time To Response (TTR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] [Срок оценки: 1 year, 2 years and 5 years]
Progression Free Survival (PFS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] [Срок оценки: 1 year, 2 years and 5 years]
Overall Survival (OS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] [Срок оценки: 1 year, 2 years and 5 years]
Maximum reduction in tumour size [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] [Срок оценки: 1 year, 2 years and 5 years]
Duration of Response (DoR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] [Срок оценки: 1 year, 2 years and 5 years]
To evaluate the viral persistence of ATTR-01 [Срок оценки: 1 year]
To evaluate the immunogenicity of ATTR-01 [Срок оценки: 1 year]

Критерии участия

Критерии включения

Consenting male and female adults (18 years of age) with select solid epithelial tumour indications known to have high frequency (75 percent) of αvβ6 integrin receptor expression as detailed in the applicable SP.
Received and failed/intolerant of Standard of Care (SoC) therapy where eligible (not including neoadjuvant).
Tumour lesion (not previously irradiated), suitable for safe pre- and post-treatment biopsies.
Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Minimum life expectancy anticipated to be greater than three months
Willing to undertake appropriate measures of hygiene to prevent any spread of virus and protection of vulnerable individuals.
Adequate organ function.
Compliant with requirements for prior treatment washout and contraceptive measures applicable to genetically modified organisms (GMOs) and cancer therapies
Prior immune checkpoint antibody therapies as single agents or in combination with other anti-cancer agents is permissible.

Критерии исключения

Significant degree of fibrotic disease, including autoimmune diseases (e.g. systemic lupus, rheumatoid arthritis) or idiopathic and occupation-related pulmonary fibrosis.
Known prior history of intolerance to anti-programmed cell death protein 1 (PD-1) and/or anti-PD-L1 immunotherapy due to toxicity.
Has any of the comorbid conditions listed in the detailed protocol exclusion criteria.

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

Здоровые добровольцы: Нет