Идёт набор NCT07110584

Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors

Фаза I / Фаза II С лечением Advanced 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: MDX2004.
Кому может быть актуально: Состояния в реестре: Advanced 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, Израиль
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Официальное название

A Phase 1/2, Multi-Center, Open-Label Clinical Study Evaluating MDX2004 In Participants With Advanced Tumors

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.

All Study Parts: Adverse Events (AEs) [Срок оценки: Baseline until 90 days after the participant has the last dose of MDX2004]
Part A only - Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D) [Срок оценки: 28 days]
Part B, C, and D: Objective response rate of MDX2004 [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]

Вторичные конечные точки (12)

All Study Parts: Measure of terminal half-life (t1/2) of MDX2004 [Срок оценки: 6 months]
All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2004 [Срок оценки: 6 months]
All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2004 [Срок оценки: 6 months]
All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2004 [Срок оценки: 6 months]
All Study Parts: Measure of volume of distribution (Vd) of MDX2004 [Срок оценки: 6 months]
All Study Parts: Measure of system clearance of MDX2004 [Срок оценки: 6 months]
All Study Parts: Evaluation of MDX2004 immunogenicity [Срок оценки: 6 months]
All Study Parts: Pharmacodynamic characterization of MDX2004 [Срок оценки: 6 months]
All Study Parts: Duration of Response (DoR) [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]
All Study Parts: Time to Response [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]
All Study Parts: Disease Control Rate (DCR) [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]
All Study Parts: Progression Free Survival (PFS) [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]

Participant must be ≥ 18 years of age.
Histologically or cytologically confirmed diagnosis of locally advanced or metastatic malignancy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
All participants should have at least 1 measurable site of disease according to RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.
Adequate hematologic, hepatic and renal function.
All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Capable of giving signed informed consent.

Any clinically significant cardiac disease.
Unresolved toxicities from previous anticancer therapy.
Known untreated, active, or uncontrolled brain metastases.
Previous Grade 3 or 4 immune-related toxicity that led to the discontinuation of treatment, within 6 months prior to the first dose of MDX2004.
Active medical condition requiring chronic systemic steroid use (>10 mg/day prednisone or equivalent) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2004.
Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.
Prior solid organ or hematologic transplant
Require supplemental oxygen for activities of daily living
Participant is not suitable for participation, whatever the reason, as judged by the Investigator including medical or clinical conditions.

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

Здоровые добровольцы: Нет