Набор скоро начнётся NCT07688577

XTX501 in Patients With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors

Фаза I / Фаза II С лечением Metastatic NSCLC - Non-Small Cell Lung Cancer Advanced Solid Tumor

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: XTX501.
Кому может быть актуально: Состояния в реестре: Metastatic NSCLC - Non-Small Cell Lung Cancer, Advanced Solid Tumor. 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: Список центров уточняется — проверьте первичный протокол.
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 First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX501 in Participants With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors

Обзор

This is a first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety and tolerability of XTX501 as monotherapy in participants with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors.

Подробное описание

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, PK, pharmacodynamics, immunogenicity, and antitumor activity of XTX501, an investigational bispecific PD-1/masked IL-2 in participants with metastatic NSCLC and select advanced solid tumors.

Phase 1, Part 1A will examine XTX501 monotherapy in a Bayesian Optimal Interval design to determine the maximum tolerated dose up to 10 dose regimens.

Phase 1, Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s).

Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s).

Вмешательства

Препарат XTX501
XTX501 monotherapy

Первичные конечные точки

Incidence of Dose Limiting Toxicities (DLTs) in Part 1A [Срок оценки: Cycle 1 Day 1 up to just prior to the second dose of study drug (approximately 21 days)]
Incidence of treatment-emergent adverse events (Phase 1 and Phase 2) [Срок оценки: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
Incidence of serious adverse events (Phase 1 and Phase 2) [Срок оценки: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
Incidence of significant change from baseline in clinical laboratory values (Phase 1 and Phase 2) [Срок оценки: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
Investigator-assessed objective response rate (ORR) per RECIST v1.1 (Phase 2) [Срок оценки: Up to Safety Follow Up Period (90 [+7] days after the last dose)]

Вторичные конечные точки (12)

Investigator-assessed objective response rate (ORR) per RECIST v1.1 (Phase 1) [Срок оценки: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
Investigator-assessed duration of response (DOR) per RECIST v1.1 (Phase 1 and Phase 2) [Срок оценки: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
Investigator-assessed disease control rate (DCR) per RECIST v1.1 (Phase 2) [Срок оценки: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
Investigator-assessed progression free survival (PFS) per RECIST v1.1 (Phase 2) [Срок оценки: Up to Safety Follow Up Period (90 [+7] days after the last dose)]
Incidence and persistence of antidrug antibodies (ADAs) (Phase 1 and Phase 2) [Срок оценки: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
Maximum observed plasma concentration (Cmax) (Phase 1 and Phase 2) [Срок оценки: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
Time of maximum observed concentration (Tmax) (Phase 1 and Phase 2) [Срок оценки: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
Trough concentrations (Ctrough) (Phase 1 and Phase 2) [Срок оценки: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
Area under the curve (AUC) (Phase 1 and Phase 2) [Срок оценки: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
Half-life (t1/2) (Phase 1 and Phase 2) [Срок оценки: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
Systemic clearance (CL) (Phase 1 and Phase 2) [Срок оценки: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]
Volume of distribution (Vd) (Phase 1 and Phase 2) [Срок оценки: Up to End of Treatment (within 10 days of the decision to discontinue XTX501)]

Критерии участия

Критерии включения

Measurable disease at baseline per RECIST v1.1
ECOG performance status of 0 or 1
Adequate organ function
Metastatic NSCLC:

Must have histologically confirmed metastatic NSCLC.
Tumor must have been assessed for EGFR and ALK per local standard of practice; patients with these driver mutations are excluded.
Patients with tumors known to have the following alterations are excluded: ROS1, RET, MET, HER-2, NTRK 1/2/3.
Patients must have previously derived clinical benefit from a PD-1/PD-L1 inhibitor or PD-1/PDL-1 bispecific without progression for at least 6 months.