Идёт набор NCT07362888

First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors

Фаза I С лечением Solid Tumors (Phase 1)

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: ADCE-B05.
Кому может быть актуально: Состояния в реестре: Solid Tumors (Phase 1). 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 First-in-Human, Phase 1a/1b, Open-Label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of the Antibody Drug Conjugate ADCE-B05 in Patients With Advanced Solid Tumors

Обзор

The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.

Подробное описание

Safety and tolerability will be evaluated by incidence of DLTs. Efficacy will be evaluated by antitumor activity: ORR, DOR, PFR, and TTR per RECIST v 1.1

Вмешательства

Препарат ADCE-B05
Biological: Antibody-drug conjugate (ADC)

Первичные конечные точки

Determine the MTD/maximum administered dose of ADCE-B05 [Срок оценки: From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)]
Assess the safety and tolerability of ADCE-B05 [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]

Вторичные конечные точки (11)

Maximum concentration (Cmax) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
Time to maximum concentration (Tmax) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
Terminal half-life (T[1/2]) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
Area under the concentration-time curve (AUC) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
Total antibody (TAb) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
Free (de-conjugated) payload [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
Objective response rate (ORR) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
Duration of response (DOR) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
Progression-free survival (PFS) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
Disease Control Rate (DCR) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]
Time to Response (TTR) [Срок оценки: Throughout the trial duration, completion expected approximately 18 months from completed enrollment]

Критерии участия

Критерии включения

Histologically or cytologically confirmed diagnosis of solid tumor
Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies
Radiologically or clinically determined progressive disease during or after most recent line of therapy
Measurable disease per RECIST 1.1
ECOG performance status of 0 or 1
Adequate hematological and biochemical parameters
A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate
A female patient who is not pregnant, not breast feeding, and either not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment

Критерии исключения

Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration
Prior treatment with an ADC containing a topoisomerase I inhibitor payload
Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required
Other malignancy
Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration
Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment
Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1
Clinically significant cardiovascular disease
Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2
Current active liver disease due to hepatitis B or hepatitis C
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis

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

Здоровые добровольцы: Нет