Идёт набор NCT07238075

ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers

Фаза I С лечением Advanced Malignancy Advanced Solid Cancers Metastatic Solid Tumors

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: ADCX-020.
Кому может быть актуально: Состояния в реестре: Advanced Malignancy, Advanced Solid Cancers, Metastatic Solid Tumors. 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, Испания
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 Dose Escalation and Multiple Cohort Expansion Phase 1a/b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ADCX-020 in Participants With Locally Advanced or Metastatic Solid Tumors

Обзор

The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors. ADCX-020 is an investigational anticancer therapy called antibody drug conjugate. This study is set up in multiple parts. In the first part of the study, participants receive increasing doses of ADCX-020. Then 2 or more doses will be assessed to identify the optimal dose. This optimal dose is subsequently evaluated for effect on different cancer types.

Подробное описание

This is a first-in-human (FIH) open-label, multicenter, dose escalation and multiple cohort expansion Phase 1a/b study to investigate safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of ADCX-020 monotherapy in participants with relapsed or refractory solid tumors, or who are intolerant to standard of care.

During dose escalation, Phase 1a, participants will receive escalating doses of ADCX-020 to identify the MTD based on the observation of DLTs. Intermediate and higher dose levels as well as alternative dosing regimens may be investigated during this part of the study.

Dose expansion, Phase 1b, will be initiated with a dose optimization of ADCX-020 using two or more dose levels of ADCX-020 and/or evaluating a different dosing regimen. Expansion in multiple cohorts is planned for selected patient populations using the RP2D.

Phase 1a will be overseen by a Dose Escalation Committee (DEC) and Phase 1b will be overseen by a Safety Review Committee (SRC).

Вмешательства

Препарат ADCX-020
ADC

Первичные конечные точки

Ph1a: To determine the safety and tolerability of ADCX-020 [Срок оценки: Start of treatment until 30 days after last dose]
Ph1a: To determine the maximun tolerated dose (MTD) or recommended dose range for expansion and optimization [Срок оценки: Start of treatment to end of DLT observation period]
Ph1b: To determine the recommended Phase 2 dose (RP2D) [Срок оценки: Baseline to 30 days post last study drug administration]
Ph1b: To assess the objective response rate (ORR) of ADCX-020 [Срок оценки: Baseline until the date of the first documented disease progression, death, or start of new anticancer therapy (approximately 24 months)]

Вторичные конечные точки (9)

To evaluate duration of objective response (DoR) [Срок оценки: Baseline until approximately 24 months]
To evaluate the disease control rate (DCR) [Срок оценки: Baseline until approximately 24 months]
To assess prgression free survival (PFS) [Срок оценки: Baseline until approximately 24 months]
Phase 1b: To evaluate overall survival (OS) [Срок оценки: Baseline to approximately 24 months]
To determine the plasma concentration of ADCX-020 [Срок оценки: Start of treatment until 30 days after last dose]
To determine the time to Cmax (Tmax) for ADCX-020 [Срок оценки: Start of treatment until 30 days after last dose]
To determine the terminal phase elimination half-life (t1/2) for ADCX-020 [Срок оценки: Start of treatment until 30 days after last dose]
To determine the area under the plasma concentration-time curve (AUC) for ADCX-020 [Срок оценки: Start of treatment until 30 days after last dose]
To evaluate the immunogenicity of ADCX-020 [Срок оценки: Start of treatment until 30 days after last dose]

Критерии участия

Критерии включения

Male and female participants ≥ 18 years of age
Ph1a: Locally advanced or metastatic solid tumor relapsed or PD following local standard treatments, for which no standard treatment is available
Ph1b: Eligible patients should have only received prior lines of systemic therapy according to SoC in the advanced/metastatic setting (not counting neoadjuvant/adjuvant treatment if completed >6 months prior to recurrence)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Radiologically measurable disease by RECIST v1.1
Mandatory adequate tumor tissue sample available
Must have recovered from all clinically relevant toxicities from previous cancer therapies (to at least Grade 1, except for alopecia)

Критерии исключения

Known allergies/hypersensitivity/intolerance to or contraindication to exatecan, or any excipient
Phase 1b: Prior antibody drug conjugate exposure with a topoisomerase 1 inhibitor payload
Uncontrolled or significant cardiac disease including left ventricular ejection fraction (LVEF) <50%, myocardial infarction or uncontrolled/unstable angina
Has clinically active central nervous system (CNS) metastases
Has a history of lung fibrosis or non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Active corneal disease, or history of corneal disease within 12 months prior to enrollment
Other unacceptable abnormalities, medications or procedures as defined by protocol

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

Здоровые добровольцы: Нет