Идёт набор NCT07439653

A Study of TORL-5-700 in Relapsed/Refractory Non Hodgkin's Lymphoma

Фаза I / Фаза II С лечением Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

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: TORL-5-700, TORL-5-700 at MTD/RP2D, TORL-5-700 at MTD/RP2D in combination with another agent.
Кому может быть актуально: Состояния в реестре: Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma. 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
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, First-in-Human, Open-Label, Multicenter Study of TORL-5-700 as a Monotherapy and in Combination for Participants With Relapsed or Refractory Non-Hodgkin Lymphoma

Обзор

A Phase 1/2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a monotherapy and in combination in R/R NHL

Вмешательства

Препарат TORL-5-700
Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks
Препарат TORL-5-700 at MTD/RP2D
Part 2: Monotherapy Expansion - TORL-5-700 at Maximum tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) Administered once every three weeks
Препарат TORL-5-700 at MTD/RP2D in combination with another agent
Part 3: Combination Evaluation - TORL-5-700 at MTD/RP2D administered every three weeks in combination with another agent

Первичные конечные точки

Evaluate the safety of TORL-5-700 as a monotherapy [Срок оценки: though study completion, an average of 2.5 years]
Assess the antitumor activity of TORL-5-700 as monotherapy [Срок оценки: though study completion, an average of 2.5 years]
Evaluate the safety of TORL-5-700 in combination with other agents [Срок оценки: though study completion, an average of 2.5 years]
Determine the Maximum Tolerated Dose (MTD) [Срок оценки: 21 days from the start of treatment]
Determine the Recommended Phase 2 Dose (RP2D) [Срок оценки: 21 days from the start of treatment]

Вторичные конечные точки (12)

Maximum Serum Concentration of TORL-5-700 (Cmax) [Срок оценки: though end of study treatment, an average of 5 months]
Maximum Serum Concentration of TORL-5-700 (Cmax) in combination with other agents [Срок оценки: though end of study treatment, an average of 5 months]
Terminal Half-life (t1/2) of Serum TORL-5-700 [Срок оценки: though end of study treatment, an average of 5 months]
Terminal Half-life (t1/2) of Serum TORL-5-700 in combination with other agents [Срок оценки: though end of study treatment, an average of 5 months]
Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration [Срок оценки: though end of study treatment, an average of 5 months]
Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration in combination with other agents [Срок оценки: though end of study treatment, an average of 5 months]
Clearance (CL) of TORL-5-700 [Срок оценки: though end of study treatment, an average of 5 months]
Clearance (CL) of TORL-5-700 in combination with other agents [Срок оценки: though end of study treatment, an average of 5 months]
Volume of distribution of TORL-5-700 [Срок оценки: though end of study treatment, an average of 5 months]
Volume of distribution of TORL-5-700 in combination with other agents [Срок оценки: though end of study treatment, an average of 5 months]
Immunogenicity of TORL-5-700 [Срок оценки: though end of study treatment, an average of 5 months]
Immunogenicity of TORL-5-700 in combination with other agents [Срок оценки: though end of study treatment, an average of 5 months]

Критерии участия

Критерии включения

Confirmed B-NHL, including but not limited to de novo DLBCL; FL, Grades 1 to 3A; MCL; transformed lymphoma (tFL, RT) and FL Grade 3B; MZL and MALT.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
At least 1 measurable lesion per Lugano criteria.
Tumor tissue is available.
Adequate organ function