Идёт набор NCT05607498

First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma

Фаза I С лечением Advanced/Metastatic Solid Tumors Relapse/Refractory 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: EMB07.
Кому может быть актуально: Состояния в реестре: Advanced/Metastatic Solid Tumors, Relapse/Refractory 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: Австралия, Китай
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, Phase I, Open-Label Study of EMB-07, a Bi-specific Antibody Anti-CD3 and Receptor Tyrosine Kinase-like Orphan Receptor 1 (ROR1) in Patients With Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma

Обзор

For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.

Подробное описание

This is a phase I, multicenter, open label, dose escalation, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose for EMB-07 in patient with locally advanced/metastatic solid tumors or relapse/refractory Lymphoma . Pharmacokinetics, pharmacodynamics, immunogenicity and response will also be assessed.

Вмешательства

Препарат EMB07
EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI

Первичные конечные точки

Incidence and severity of adverse events as assessed by CTCAE V5.0. [Срок оценки: Screening up to 30 days after the last dose.]
Incidence of serious adverse events (SAE). [Срок оценки: Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related.]
Incidence of dose interruptions. [Срок оценки: Screening up to 30 days after the last dose.]
Dose intensity. [Срок оценки: Screening up to 30 days after the last dose.]
The incidence of DLTs during the first cycle of treatment. [Срок оценки: First infusion to the end of cycle 1. (each cycle is 28 days).]

Вторичные конечные точки (10)

Overall response rate. [Срок оценки: From the date of dosing untill the date of first documented progression or date of death from any casue, whichever case first, expected average 6 months.]
Area under the serum concentration-time curve (AUC) of EMB-07. [Срок оценки: Through treatment until EOT visit, expected average 6 months.]
Maximum serum concentration (Cmax) of EMB-07. [Срок оценки: Through treatment until EOT visit, expected average 6 months.]
Trough concentration (Ctrough) of EMB-07. [Срок оценки: Through treatment until EOT visit, expected average 6 months.]
Average concentration over a dosing interval (Css, avg) of EMB-07. [Срок оценки: Through treatment until EOT visit, expected average 6 months.]
Terminal half-life (T1/2) of EMB-07. [Срок оценки: Through treatment until EOT visit, expected average 6 months.]
Systemic clearance (CL) of EMB-07. [Срок оценки: Through treatment until EOT visit, expected average 6 months.]
Steady state volume of distribution (Vss) of EMB-07. [Срок оценки: Through treatment until EOT visit, expected average 6 months.]
Progression free survival (PFS) of EMB-07 as assessed by RECIST 1.1, iWCLL-2018, Lugano 2014 [Срок оценки: Through treatment discontinuation: an average of 6 months]
Incidence and titer of anti-drug antibodies stimulated by EMB-07. [Срок оценки: Up to End of Treatment Follow Up Period (30 days after the last dose)]

Критерии участия

Критерии включения

Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
Male or female, and aged ≥ 18 years
Treatment group A: Patients with histologically or cytologically locally advanced unresectable or metastatic solid tumors limiting to triple-negative breast cancer, lung adenocarcinoma, ovarian cancer, pancreatic cancer, colorectal cancer, gastric cancer, prostate cancer, bladder cancer, and uterus cancer. Treatment group B: Patients with histologically or cytologically relapse/refractory lymphoma limiting to chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL).
Treatment group A: Standard therapies do not exist, or are no longer effective, or are not tolerable or accessible to the patient measurable or evaluable disease per RECIST V1.1. Treatment group B: Presence of at least one two-dimensional measurable lesion confirmed by imaging (CT or MRI) (either lymph nodes lesions with any long diameter > 1.5 cm or extranodal lesions with any long diameter > 1.0 cm); for CLL patients whose baseline imaging evaluation determined that no two-dimensional measurable lesions, their peripheral blood monoclonal B lymphocytes should be ≥ 5.0×109/L.
Patients must provide archival tumor samples, or a biopsy will be required if archival tumor sample is not available. Archival tumor sample must be taken ≤ 2 years prior to screening, otherwise a fresh tumor biopsy at screening is required.
ECOG performance status 0 or 1
Adequate organ function to participate in the trial.
Recovery from adverse events (AEs) related to prior anticancer therapy.

Критерии исключения

Prior treatment with any agent targeting ROR1.
History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies.
Patient with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with solid tumors with CNS metastases are eligible if they do not need to receive local radiation treatment at the discretion of investigator or if radiation therapy for CNS metastases is completed ≥ 4 weeks prior to study treatment.
Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment.
Abuse on alcohol, cannabis-derived products, or other drugs.

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

Здоровые добровольцы: Нет