Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors

Официальное название

A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Обзор

The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.

Вмешательства

• Препарат IBI3020
  Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection

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 electrocardiogram [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 21 days]
• objective response rate (ORR) [Срок оценки: Up to 3 years]
• Number of subjects with clinically significant changes in laboratory parameters [Срок оценки: Up to 3 years]

Вторичные конечные точки (12)

• 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]
• disease control rate (DCR) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

Participants must satisfy all of the following criteria to be enrolled into the study:

• Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
• Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;
• Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications;
• At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
• Minimum life expectancy of 12 weeks;
• Adequate bone marrow and organ function confirmed at screening period;
• Participants, both male and female, who are not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study.

Критерии исключения

Participants who meet any of the following criteria will be disqualified from entering the study:

• Previous treatment with CEACAM5-targeted therapy;
• Prior anti-cancer therapy within the wash-out period;
• Received live vaccines within 4 weeks or cancer vaccine within 3 months;
• Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;
• Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0;
• Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients;
• Undergone major surgery within 4 weeks, or who have severe unhealed wounds;
• Known symptomatic central nervous system (CNS) metastases;
• Uncontrolled diseases or conditions;
• History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases;
• History of thromboembolic event within 6 months;
• Under neurological, psychiatric or social condition;
• Women who are pregnant, have positive results in pregnancy test or are lactating;
• Not eligible to participate in this study at the discretion of the investigator;
• Participating in any other interventional clinical research.

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

США · 6 центров

• Mayo Clinic - Arizona — Pheonix
• Mayo Clinic - Florida — Jacksonville
• Mayo Clinic - Rochester — Rochester
• Montefiore Cancer Center — New York
• NEXT Houston — Houston
• NEXT Dallas — Irving

Китай · 3 центра

• The sixth affiliated hospital, Sun Yat-sen University — Гуанчжоу
• Shandong Cancer Hospital — Цзинань
• Shanxi Cancer Hospital — Taiyuan

Идентификаторы

NCT: NCT06963281 · "CIBI3020A101"

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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