Идёт набор NCT05958121

IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

Фаза I / Фаза II С лечением Refractory Cancer Recurrent Cancer Solid Tumor, Adult Cancer

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: IMA402, IMA402 and checkpoint inhibitor, IMA402 and chemotherapy, IMA402 and IMA401.
Кому может быть актуально: Состояния в реестре: Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult, Cancer. 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: Германия, Нидерланды
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 I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors

Обзор

The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors. Primary objectives: * To determine the maximum tolerated doses and/or recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia) * To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I/II) * To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II) Secondary objectives: * To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I) * To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II) * To describe the PK of IMA402 as monotherapy and in combination (Phase I/II)

Подробное описание

The study will be conducted in two phases:

* Phase Ia: Dose escalation/de-escalation * Phase Ib: Dose extension * Phase II: Dose extension in selected Indication-specific extension cohort(s) (ISEC)

Вмешательства

Препарат IMA402
IV infusions
Препарат IMA402 and checkpoint inhibitor
IMA402 IV infusions and checkpoint inhibitor
Препарат IMA402 and chemotherapy
IMA402 IV infusions and chemotherapy
Препарат IMA402 and IMA401
IMA402 and IMA401 IV infusions
Препарат IMA402 and monoclonal antibody
IMA402 IV infusions and monoclonal antibody
Препарат IMA402 and chemotherapy +/- monoclonal antibody
IMA402 IV infusions and chemotherapy +/- monoclonal antibody

Первичные конечные точки

Phase I: Number of patients with dose limiting toxicities (DLTs) [Срок оценки: 24 months]
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs) [Срок оценки: 40 months]
Phase I/II: Number of patients with serious TEAEs [Срок оценки: 40 months]
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations [Срок оценки: 40 months]
Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations [Срок оценки: 40 months]
Phase II: Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) [Срок оценки: 40 months]

Вторичные конечные точки (10)

Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST [Срок оценки: 37 months]
Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST [Срок оценки: 40 months]
Phase I/II: Disease control rate (DCR) of CR, PR or stable disease (SD) (lasting 6 or more weeks) following the initiation of IMA402 based on RECIST v1.1 and iRECIST [Срок оценки: 40 months]
Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST [Срок оценки: 40 months]
Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST [Срок оценки: 40 months]
Phase I/II: Overall survival (OS) [Срок оценки: 40 months]
Phase I/II: Determination of PK parameter: half-life (t1/2) [Срок оценки: 40 months]
Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin) [Срок оценки: 40 months]
Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax) [Срок оценки: 40 months]
Phase I/II: Determination of PK parameter: area under the curve (AUC) [Срок оценки: 40 months]

Критерии участия

Критерии включения

Patients ≥ 18 years old
Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication
Patients must have received or not be eligible for indicated standard-of-care treatments per cohort
Measurable disease according to RECIST 1.1
Confirmed HLA status
ECOG Performance Status of 0 to 1
Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status

Критерии исключения

Other active malignancies that require treatment or that might interfere with the trial endpoints
The patient is pregnant or is breastfeeding
History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product
The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures
Patients with active brain metastases, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation

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

Здоровые добровольцы: Нет