Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Официальное название

A Multicenter, Open-label, Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI3005 in Subjects With Advanced Malignant Solid Tumors

Обзор

The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.

Вмешательства

• Препарат IBI3005
  Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)

Первичные конечные точки

• Numbers of subjects with adverse events [Срок оценки: Up to 3 years]
• Number of subjects with clinically significant changes in physical examination results [Срок оценки: Up to 3 years]
• Number of subjects with clinically significant changes in vital signs [Срок оценки: Up to 3 years]
• Dose limiting toxicities (DLTs) [Срок оценки: Up to 4 weeks]

Вторичные конечные точки (11)

• area under the curve (AUC) [Срок оценки: up to 3 years]
• maximum concentration (Cmax) [Срок оценки: up to 3 years]
• time to maximum concentration (Tmax) [Срок оценки: up to 3 years]
• clearance (CL) [Срок оценки: up to 3 years]
• apparent volume of distribution (V) [Срок оценки: up to 3 years]
• half-life (t1/2) [Срок оценки: up to 3 years]
• anti-drug antibody (ADA) [Срок оценки: up to 3 years]
• objective response rate (ORR) [Срок оценки: up to 3 years]
• duration of response (DoR) [Срок оценки: up to 3 years]
• time to response (TTR) [Срок оценки: up to 3 years]
• progression free survival (PFS) [Срок оценки: up to 3 years]

Критерии участия

Критерии включения

Subjects Should have been previously treated with a third-generation EGFR TKI with disease progression. Subjects with positive other driver genes or METex14 mutations are required to undergo targeted therapy and disease progression.

Критерии исключения

Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study.Patients are allowed to receive inactivated vaccines.

Uncontrolled diseases including:

• Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug（ antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed）;
• Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
• Acute or chronic active hepatitis B (HbsAg positive and/or HbcAb positive with HBV DNA titer ≥ 104 copies/mL or ≥ 2000 IU/mL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer > 103 copies/mL or higher than lower limit of detection);
• Active COVID-19 infection with obvious symptoms requiring treatment or hospitalization, such as pyrexia, dyspnea, nausea, vomiting, diarrhea, etc.;
• Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti tuberculosis therapy within 1 year prior to first administration of the study drug;
• Active syphilis infection or latent syphilis requiring treatment;
• Symptomatic congestive heart failure Grade II-IV (New York Heart Association \[NYHA\]), symptomatic or uncontrolled arrhythmias, QTc interval > 480 ms or personal or family history of congenital long/short QT syndrome;
• Hypertension that does not receive standardized therapy or still uncontrollable hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg); Any history of life-threatening hemorrhage, or hemorrhage requiring (including but not limited to gastrointestinal bleeding, hemoptysis, etc) blood transfusion, endoscopy, or surgery, within 3 months prior to the first administration of study drug;

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shandong Cancer Hospital & Institute — Цзинань

Идентификаторы

NCT: NCT06418061 · CIBI3005A101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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