Evaluation of ICP-B794 in Patients With Advanced Solid Tumors

Официальное название

An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients With Advanced Solid Tumors

Обзор

An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients with Advanced Solid Tumors

Вмешательства

• Препарат ICP-B794
  Intravenous administration once every 3 weeks

Первичные конечные точки

• Incidence, character, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0 [Срок оценки: Up to 2 years]
• Dose-limiting toxicities (DLT) [Срок оценки: Up to 2 years]
• The Recommended Dose (RD) of ICP-B794 for expansion and Maximum Tolerated Dose (MTD) [Срок оценки: Up to 2 years]
• Objective response rate (ORR) [Срок оценки: Up to 2 years]

Вторичные конечные точки (12)

• Maximum Plasma Concentration (Cmax) [Срок оценки: Up to 2 years]
• Time to Maximum Plasma Concentration (Tmax) [Срок оценки: Up to 2 years]
• Half-life (T1/2) [Срок оценки: Up to 2 years]
• Area under the concentration-time curve from zero time to infinity (AUC0-∞) [Срок оценки: Up to 2 years]
• Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t) [Срок оценки: Up to 2 years]
• Apparent Clearance (CL/F) [Срок оценки: Up to 2 years]
• Terminal Apparent Volume of Distribution (Vz/F) [Срок оценки: Up to 2 years]
• Objective Response Rate (ORR) [Срок оценки: Up to 2 years]
• Disease control rate (DCR) [Срок оценки: Up to 2 years]
• Duration of response (DOR) [Срок оценки: Up to 2 years]
• Progression-Free Survival (PFS) [Срок оценки: Up to 2 years]
• Radiographic progression-free survival (rPFS) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Age ≥18 years and ≤75 years.
• Histologically confirmed other locally advanced or metastatic solid tumors.
• Life expectancy ≥3 months.
• Adequate organs function within 7 days prior to the first dose of ICP-B794
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1。
• At least one measurable lesion per RECIST V1.1 criteria.
• Able to provide archived tumor tissue sample (within 2 years) or fresh tumor tissue sample.
• Female participants of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening.
• WOCBP and male participants must agree to use contraceptive method.
• Female participants must not breastfeed or plan pregnancy during the study and for at least 6 months after the last dose of investigational drug.
• Participants must be able to communicate effectively with investigators and comply with all study requirements.
• Participants voluntarily joined the study and signed the informed concent form (ICF).

Критерии исключения

• Other active primary malignancies within 3 years prior to the first dose of investigational product.
• Prior or current treatment with the similar drug or related treatment specified in the protocol.
• Having a past medical history and unhealthy lifestyle history as specified in the protocol, or suffering from diseases as specified in the protocol.
• Toxicities from prior anti-tumor therapy not recovered to ≤ Grade 1 (per CTCAE V5.0).
• Major arterial or venous thrombotic events within 3 months prior to first dose.
• Active bleeding within 2 months prior to screening or history of clinically significant bleeding tendency.
• Major surgery within 28 days prior to first dose or minor surgery within 2 weeks prior to first dose.
• Requirement for systemic corticosteroid therapy within 14 days prior to first dose.
• History of severe hypersensitivity, or known severe hypersensitivity to the active pharmaceutical ingredient, inactive ingredients in the drug product, or antibody-based drugs, or hypersensitivity to recombinant human or murine proteins, or history of severe infusion reaction.
• Administration of any live vaccine within 4 weeks prior to first dose or history of hypersensitivity reactions of any grade.
• Female participants who are pregnant, lactating, or planning pregnancy during the study.
• Any psychiatric or cognitive disorder that may impair understanding or execution of the informed consent document and/or protocol compliance
• Other conditions determined by the investigator that render patients unsuitable for participation in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07136558 · ICP-CL-01501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗