Идёт набор NCT06974110

Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors

Фаза I С лечением Advanced Solid Tumor Metastatic Solid Tumor Endometrial Cancer MSI-H 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: MOMA-341, Irinotecan, Immunotherapy.
Кому может быть актуально: Состояния в реестре: Advanced Solid Tumor, Metastatic Solid Tumor, Endometrial Cancer, MSI-H 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: США, Австралия
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 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors

Обзор

This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.

Подробное описание

MOMA-341 is a novel therapeutic agent designed to target microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) cancers by inhibiting Werner helicase. MOMA-341 is being developed as a single agent and in combination with either chemotherapy or immunotherapy in patients with certain advanced or metastatic solid tumors.

This phase 1, first-in-human, open-label study of MOMA-341 is primarily intended to evaluate the safety and tolerability of MOMA-341 when administered orally as a single agent (Treatment Arm 1), in combination with irinotecan (Treatment Arm 2), or in combination with immunotherapy (Treatment Arm 3). Each treatment arm of the study includes a dose-escalation phase, which means successive cohorts of patients will receive increasing oral doses of MOMA-341 as a single agent or in combination with irinotecan or immunotherapy to determine the presumptive optimal biologic dose(s) (OBD) in this population. The study also includes a dose-optimization phase that will enroll additional patients to support the confirmation of the OBD.

The data from this study conducted in patients with MSI-H or dMMR advanced or metastatic solid tumors, including safety, tolerability, PK/PDx findings, and antitumor activity, will form the basis for subsequent clinical development of MOMA-341 as a single-agent and in combination with irinotecan or immunotherapy.

Вмешательства

Препарат MOMA-341
MOMA-341 administered orally
Препарат Irinotecan
Irinotecan administered by IV infusion
Препарат Immunotherapy
Immunotherapy administered by IV infusion

Первичные конечные точки

Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation [Срок оценки: From screening until treatment discontinuation (up to 35 months)]

Вторичные конечные точки (12)

Identify the recommended phase 2 dose (RP2D) [Срок оценки: From screening until treatment discontinuation (up to 35 months)]
PK parameter; area under curve (AUC) of MOMA-341 [Срок оценки: Up to 6 weeks with sparse sampling up to 35 months]
PK parameter; maximum concentration (Cmax) of MOMA-341 [Срок оценки: Up to 6 weeks with sparse sampling up to 35 months]
PK parameter; time to maximum concentration (Tmax) of MOMA-341 [Срок оценки: Up to 6 weeks with sparse sampling up to 35 months]
PK parameter; half-life (T1/2) of MOMA-341 [Срок оценки: Up to 6 weeks with sparse sampling up to 35 months]
PK parameter; plasma exposure of irinotecan [Срок оценки: Up to 6 weeks with sparse sampling up to 35 months]
Objective response rate (ORR) [Срок оценки: Up to 35 months]
Duration of response (DOR) [Срок оценки: Up to 35 months]
Time to response (TTR) [Срок оценки: Up to 35 months]
Progression free survival (PFS) [Срок оценки: Up to 35 months]
Disease control rate (DCR) [Срок оценки: Up to 35 months]
Overall survival (OS) [Срок оценки: Up to 35 months]

Критерии участия

Критерии включения

Age ≥ 18 years
Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants must have previously received and progressed on an anti-PD-(L)1-based regimen, unless ineligible or in a region without access to anti-PD-(L)1 therapies
Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3
ECOG PS ≤ 2
Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery \*\*hormonal therapy allowed. Palliative radiotherapy allowed
Adequate organ function per local labs
Comply with contraception requirements
Written informed consent must be obtained according to local guidelines

Критерии исключения

Known Werner Syndrome
Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)
Clinically relevant cardiovascular disease
Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
Known active uncontrolled infection
Known allergy, hypersensitivity, and/or intolerance to MOMA-341
Impaired GI function that may impact absorption
Patient is pregnant or breastfeeding
Known to be HIV positive, unless all of the following criteria are met:

Undetectable viral load or CD4+ count ≥300 cells/μL
Receiving highly active antiretroviral therapy
No AIDS-related illness within the past 12 months
Active liver disease (some exceptions are allowed)
Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and/or interfere with the patients participation in the study

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

Здоровые добровольцы: Нет