Идёт набор NCT06622486

First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors

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: EGL-001.
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: Франция, Испания
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

First-in-human Phase 1/2 Trial of EGL-001 in Adult Patients with Selected Advanced And/or Metastatic Solid Tumors

Обзор

This multicenter, open-label, first-in-human, Phase 1/2 study consists of a Part 1 (Phase 1) open-label dose escalation of EGL-001 administered as a single agent and in combination with an anti-PD(L)-1 treatment, followed by a Part 2 (Phase 2) open-label dose expansion of EGL-001 administered at the RP2D in patients with recurrent and/or metastatic solid tumors as monotherapy and/or combination therapy with anti-PD(L)-1.

Подробное описание

In approximately 4 centers in France and 4 centers in Spain, 30 to 50 patients will be included in the dose escalation Part 1 of the trial. Number of participating countries and sites as well as patients will be defined based on Part 1 for Part 2 dose expansion phase.

Вмешательства

Препарат EGL-001
IV administration

Первичные конечные точки

To evaluate the safety, tolerability, dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) leading to the recommended Phase 2 doses (RP2Ds) [Срок оценки: Day 1 up to 90 days after last dose]
To evaluate the safety, tolerability, dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) leading to the recommended Phase 2 doses (RP2Ds) [Срок оценки: Day 1 up to 90 days after last dose]
To evaluate the safety, tolerability, dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) leading to the recommended Phase 2 doses (RP2Ds) [Срок оценки: Day 1 up to 90 days after last dose]
To evaluate the safety, tolerability, dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) leading to the recommended Phase 2 doses (RP2Ds) [Срок оценки: Day 1 up to 90 days after last dose]

Вторичные конечные точки (5)

To evaluate the preliminary antitumor efficacy (according to RECIST v1.1) [Срок оценки: From Dose 1 to to the date of first documented tumor progression or death due to any cause, whichever occurs first.]
To evaluate the preliminary antitumor efficacy (according to RECIST v1.1) [Срок оценки: From Dose 1 to to the date of first documented tumor progression or death due to any cause, whichever occurs first.]
To evaluate the preliminary antitumor efficacy (according to RECIST v1.1) [Срок оценки: From Dose 1 to to the date of first documented tumor progression or death due to any cause, whichever occurs first.]
To evaluate the preliminary antitumor efficacy (according to RECIST v1.1) [Срок оценки: From Dose 1 to to the date of first documented tumor progression or death due to any cause, whichever occurs first.]
To evaluate the preliminary antitumor efficacy (according to RECIST v1.1) [Срок оценки: From Dose 1 to to the date of first documented tumor progression or death due to any cause, whichever occurs first.]

Критерии участия

Критерии включения

Signed written informed consent
Female or male patients, aged at least 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Life expectancy of at least 3 months as assessed by the investigator
Patients with confirmed locally advanced, unresectable, or metastatic solid tumors who have been previously treated with SoC and are no longer eligible for other therapies
Patients who have been treated with an ICI treatment as monotherapy or in combination as SoC
Have recovered from previous treatment
At least 1 measurable lesion according to RECIST Version 1.1
Adequate hematological, hepatic, and renal functions
Negative blood pregnancy test at screening for women of childbearing potential
Highly effective contraception during the study period and for 6 months after the last study treatment administration for WOCBP, and for male patients who are sexually active with WOCBP. Highly effective contraception methods are defined as:

Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectable, implants, intrauterine devices such as Mirena and nonhormonal intrauterine devices such as ParaGard for WOCBP patients or male patients' WOCBP partners
Tubal ligation
Vasectomy

In addition to highly effective contraception, participating male patients:

Must use a condom during the study period and for 3 months after the last study treatment administration when engaging in any activity that allows for exposure to ejaculate
Must refrain from donating sperm
Must agree to abstain from donating blood while taking study drug and for 3 months following discontinuation of study treatment
Able to understand the character and individual consequences of clinical trial

Критерии исключения

Patients with central nervous system metastases and/or leptomeningeal carcinomatosis with some exceptions
Patients with active or a documented history of autoimmune disease, immune deficiency or syndrome that required systemic corticoids (except the allowed dose) or immunosuppressive medications
Patients who received a previous ICI like anti-PD(L)-1 or an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to toxicity
Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to the first study treatment, with exceptions. Steroids with no or minimal systemic effect (topical, inhalation) are allowed
Patients with history of or current interstitial lung disease or fibrosis, and patients with pneumonitis
Other active malignancy requiring active intervention
Patients with previous malignancies other than the target malignancy to be investigated in this trial, unless a complete remission was achieved and no additional therapy is required during the study period
Patient with any organ transplantation, including allogeneic stem cell transplantation
Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma
Any known allergy or severe reaction to any component of anti-CTLA-4 or anti-PD(L)-1 drug product
Significant chronic or acute infections requiring systemic therapy including SARS-CoV-2 (COVID-19) PCR positive testing
Clinically significant active cardiovascular disease
Any other medical conditions or psychological disorders that would increase the safety risk to the patient or interfere with participation of the patient or the evaluation of the clinical study in the opinion of the investigator
Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial

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

Здоровые добровольцы: Нет