This is a Multi-Center Study of IBI3026 in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors

Официальное название

A Multi-Center, Open-Label, Phase 1 Study of IBI3026 in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors

Обзор

This is a multicenter, open-label, phase I dose-escalation and expansion study of IBI3026 in participants with unresectable, locally advanced, or metastatic solid tumors. The study will be conducted in two phases: Phase 1 dose escalation and Phase 2 dose expansion. Safety will be monitored by the Safety Review Committee (SRC).

Вмешательства

• Препарат IBI3026
  Recombinant anti-programmed death receptor-1 (PD-1) antibody fused with interleukin-12 (IL-12) bispecific molecule injection

Первичные конечные точки

• Adverse Event [Срок оценки: up to 2 years]
• Serious Adverse Event [Срок оценки: up to 2 years]
• Maximum Tolerated Dose [Срок оценки: up to 2 years]
• DLT(Dose-limiting Toxicity) [Срок оценки: up to 2 years]

Вторичные конечные точки (9)

• PK concentration: IBI3026 serum concentration [Срок оценки: up to 2 years]
• Incidence and number of patients with ADA [Срок оценки: up to 2 years]
• Incidence and number of patients with NAb [Срок оценки: up to 2 years]
• ORR (Objective Response Rate) [Срок оценки: up to 2 years]
• DoR(Duration of Response) [Срок оценки: up to 2 years]
• DCR(Disease Control Rate) [Срок оценки: up to 2 years]
• TTR(Time to Response) [Срок оценки: up to 2 years]
• PFS(Progression-free Survival) [Срок оценки: up to 2 years]
• OS(Overall Survival) [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

• Participants must have the ability to understand and sign a written informed consent form for participation in this study, including all assessments and procedures specified in the protocol;
• Male or female participants aged ≥18 years;
• At least one measurable lesion as defined by RECIST v1.1 within 28 days prior to the first dose of IBI3026;
• ECOG performance status of 0-1;
• Life expectancy of at least 12 weeks at the start of treatment;
• The screening period confirms that bone marrow and organ functions are good.
• Male or female participants who are either of non-reproductive potential or agree to use at least one highly effective method of contraception during the study period (starting from screening or 2 weeks prior to first dosing, whichever comes first, and continuing until 6 months after the last dose of study drug);
• Not amenable to curative surgical resection or definitive chemoradiotherapy.

Критерии исключения

• Prior treatment with IL-12 class cytokines or IL-12 inhibitors;
• Participation in any interventional clinical study other than observational (non-interventional) studies, or currently in the follow-up period of an interventional study;
• Adverse reactions from prior anti-tumor therapies that have not resolved to Grade 0 or 1, or baseline levels, according to NCI CTCAE v5.0, prior to the first dose of study drug (exceptions include alopecia, fatigue, hyperpigmentation, or other conditions deemed without safety risk by the investigator);
• Prior immune checkpoint inhibitor therapy associated with severe adverse reactions sufficient to compromise participant safety;
• Known hypersensitivity, allergic reaction, or intolerance to IBI3026 or its excipients (refer to Investigator's Brochure).
• Received major surgery (e.g., craniotomy, thoracotomy, or laparotomy, or other surgeries as determined by the investigator) within 4 weeks prior to the first dose of study drug, excluding core biopsy; or anticipated to undergo major surgery during the study period; or presence of serious non-healing wounds, trauma, ulcers, etc.
• Known symptomatic central nervous system (CNS) metastases. Participants with asymptomatic CNS metastases (i.e., no neurological syndrome and metastatic lesion diameter ≤1.5 cm) or those with stable disease post-treatment as judged by the investigator may be considered under the following conditions: absence of midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord involvement; clinically stable for at least 4 weeks prior to the first dose of study drug (stable on ≤1.5 mg/day dexamethasone or equivalent corticosteroid and baseline anticonvulsant therapy), with no clinically confirmed new or enlarging CNS lesions.
• Tumor invasion into surrounding critical structures (e.g., mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal/respiratory fistula formation.

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

• Sichuan Cancer Hospital — Чэнду

Идентификаторы

NCT: NCT07327632 · CIBI3026A101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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