Набор скоро начнётся NCT07622524

A Phase I Study of CS5007 in Participants With Advanced Solid Tumors

Фаза I С лечением Advanced 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: CS5007.
Кому может быть актуально: Состояния в реестре: Advanced 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, Китай
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, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti Tumor Activities of CS5007, a Novel EGFR and HER3 Bispecific Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors

Обзор

This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.

Вмешательства

Препарат CS5007
CS5007 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).

Первичные конечные точки

[Dose Escalation] Maximum tolerated dose (MTD) of CS5007 [Срок оценки: Cycle 1 (Up to 21 Days)]
[Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS5007 [Срок оценки: Up to approximately 2 years]
[Dose Escalation] The incidence and severity of adverse events (AEs) [Срок оценки: Up to approximately 2 years]
[Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1 [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (12)

[Dose Escalation & Expansion] Area under the curve (AUC) of CS5007 [Срок оценки: Up to approximately 2 years]
[Dose Escalation & Expansion] Maximum concentration (Cmax) of CS5007 [Срок оценки: Up to approximately 2 years]
[Dose Escalation & Expansion] Time to maximum concentration (Tmax) of CS5007 [Срок оценки: Up to approximately 2 years]
[Dose Escalation & Expansion] Elimination half-life (t1/2) of CS5007 [Срок оценки: Up to approximately 2 years]
[Dose Escalation & Expansion] Clearance (CL) of CS5007 [Срок оценки: Up to approximately 2 years]
[Dose Escalation & Expansion] Volume of distribution (Vz) of CS5007 [Срок оценки: Up to approximately 2 years]
[Dose Escalation & Expansion] Trough concentration (Ctrough) of CS5007 [Срок оценки: Up to approximately 2 years]
[Dose Escalation & Expansion] Accumulation ratio (R) of CS5007 [Срок оценки: Up to approximately 2 years]
[Dose Escalation & Expansion] Number of participants with anti-CS5007 antibodies [Срок оценки: Up to approximately 2 years]
[Dose Escalation] Objective response rate (ORR) evaluated by investigators per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
[Dose Escalation & Expansion] Duration of response (DOR) evaluated by investigators per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
[Dose Escalation & Expansion] Disease control rate (DCR) evaluated by investigators per RECIST v1.1 [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

Evidence of a personally signed and dated informed consent document.
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Being ≥ 18 years of age on the day of signing informed consent.
Pathologically or cytologically confirmed, unresectable advanced solid tumors.
Participants must have at least one measurable lesion according to RECIST Version1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
Adequate organ function.
Life expectancy ≥ 3 months.
Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study drug administration

Критерии исключения

Has disease that is suitable for local treatment administered with curative intent.
Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is symptomatic, untreated, or requires therapy.
Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose.
Has uncontrolled pleural effusion, pericardial effusion, or ascites.
Has immune deficient disease or received systemic immunosuppressive treatment.
Has intestinal obstruction,or history of inflammatory bowel disease,or chronic diarrhea.
Has history of (non-infectious) interstitial lung disease/pneumonitis that required steroids.
Has active infections requiring systemic therapy.
Has significant cardiovascular disease or cerebrovascular accident within specified timeframes prior to first dose.
Insufficient washout from prior anti-tumor therapy.
Received live vaccine within 28 days prior to first dose.
History of allogeneic organ or hematopoietic stem cell transplantation.
History of hypersensitivity to excipients of study drug or any monoclonal antibody.
Any toxic effects of prior therapy unresolved to Grade ≤1.
Active alcohol or drug abuse.
Pregnant or breastfeeding women.
Other acute or chronic medical or psychiatric conditions that may increase risk or interfere with study results, in the investigator's judgment.