Идёт набор NCT07129252

A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors

Фаза I / Фаза II С лечением SST2-positive Neuroendocrine Neoplasms Neuroendocrine Tumors Neuroendocrine Neoplasm

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: CRN09682.
Кому может быть актуально: Состояния в реестре: SST2-positive Neuroendocrine Neoplasms, Neuroendocrine Tumors, Neuroendocrine Neoplasm. 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, 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

A Phase 1/2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants With Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors

Обзор

This Phase 1/2, multicenter, open-label, FIH study aims to evaluate the safety, tolerability, PK, and preliminary antitumor activity of CRN09682 in participants with SST2-expressing NENs and other solid tumors. The study includes a Dose Escalation Phase to determine the MTD and DLTs. Following MTD identification, additional participants will be enrolled at the expansion dose to further assess safety, tolerability, PK, and antitumor activity.

Вмешательства

Препарат CRN09682
Study drug CRN09682 intravenously

Первичные конечные точки

(Dose Escalation) Incidence and severity of DLTs. [Срок оценки: From first dose through Day 21.]
(Dose Escalation) Incidence and severity of AEs and SAEs at each dose level and incidence of AEs leading to discontinuation from study drug. [Срок оценки: From first dose of study drug to 30 days after the last dose.]
(Dose Expansion) Nature, incidence, and severity of AEs and SAEs at the Expansion Dose. [Срок оценки: From first dose of study drug to 30 days after the last dose.]
(Dose Expansion) Interruptions at the Expansion Dose. [Срок оценки: At Day 1 of each cycle through study completion, approximately 2 years.]

Вторичные конечные точки (10)

(Dose Escalation) Maximum Plasma Concentration (Cmax) of CRN09682 and MMAE . [Срок оценки: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.]
(Dose Escalation) Time to Maximum Concentration (Tmax) of CRN09682 and MMAE. [Срок оценки: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.]
(Dose Escalation) Measure of CRN09682 and MMAE exposure in the body from initial dose to the last measurable concentration (AUC0-last). [Срок оценки: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.]
(Dose Escalation) Measure of total CRN09682 exposure in the body across time (AUC0-inf). [Срок оценки: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.]
(Dose Escalation) The amount of time required for CRN09682 to be reduced to half of its initial concentration in the blood (t1/2). [Срок оценки: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.]
(Dose Escalation & Expansion) Objective response rate (ORR): The percentage of patients with best overall response of complete response or partial response according to RECIST 1.1 [Срок оценки: Throughout the study until disease progression or the last evaluable assessment in the absence of progression whichever occurs first, approximately 2 years.]
(Dose Escalation & Expansion) Disease control rate (DCR): The percentage of patients with best overall response of complete response, partial response, or stable disease according to RECIST 1.1 [Срок оценки: Throughout the study until disease progression or the last evaluable assessment in the absence of progression whichever occurs first , approximately 2 years.]
(Dose Escalation & Expansion) Duration of response (DOR): The time from the date of first objective response until date of disease progression or death in the absence of disease progression, according to RECIST 1.1. [Срок оценки: From the first documented objective response to disease progression or death whichever occurs first, approximately 2 years.]
(Dose Expansion) Changes in somatostatin receptor imaging: Evaluate changes in SSR tracer uptake over time, based on whether uptake is greater than or less than liver uptake. [Срок оценки: Throughout the study at predefined intervals, approximately 2 years.]
(Dose Expansion) Radiographic PFS: The time from the start of study drug until RECIST 1.1 defined disease progression or death in the absence of disease progression. [Срок оценки: Throughout the study until disease progression or death whichever occurs first, approximately 2 years.]

Критерии участия

Критерии включения

Have a histological diagnosis of metastatic or locally advanced inoperable NET, NEC, or other solid tumors that have confirmed radiological progression.
Have one or more measurable disease location per RECIST version 1.1.
Have a tumor that expresses SSR confirmed by SSR imaging.
Have an ECOG performance status of 0, 1, or 2.

Критерии исключения

Have tumor progression while undergoing a course of PRRT or within 6 months of completing PRRT.
Have brain metastases unless asymptomatic and stable for at least one month for participants with SCLC or LCLC or at least 3 months for participants with other non-NET solid tumors.
Use of anticancer agents within specified intervals prior to the first dose of study drug.
Had surgery, chemoembolization, or radiofrequency ablation within 90 days prior to first dose of study drug.
Prior participation in any intervention clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
Participants with carcinoid syndrome.
Secondary malignancy: participants who have any other malignancy known to be active or treated within 3 years of the start of screening, with the exception of treated cervical intraepithelial neoplasia, superficial (noninvasive) bladder cancer, and non-melanoma skin cancer.
Have prior treatment with MMAE.
Have hypersensitivity or history of anaphylactic reaction to octreotide, other SSAs, and/or MMAE.

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

Здоровые добровольцы: Нет