Safety and Preliminary Activity of BI115 in Advanced SCLC

Официальное название

Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants With Advanced Small Cell Lung Cancer

Обзор

This study is a multi-regional, open-label phase I study to evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants with Advanced Small Cell Lung Cancer

Вмешательства

• Препарат IBI115
  IBI115 will be administered. The Dose Limiting Toxicity (DLT) observation period will last for 28 or 21 days after first dose. After completion of the DLT observation period, subject will continue to receive IBI115 until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal od consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.

Первичные конечные точки

• Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and treatment emergent adverse events (TEAE) [Срок оценки: up to 90 days after the last administration]
• Dose-limiting toxicity (DLT) [Срок оценки: up to 28 days after the first dose of IBI115]
• MTD of IBI115 [Срок оценки: up to 90 days after the last administration]
• RDC of IBI115 [Срок оценки: up to 90 days after the last administration]
• Number of participants with clinically significant changes in physical examination results [Срок оценки: up to 90 days after the last administration]
• Number of participants with abnormal vital signs [Срок оценки: up to 90 days after the last administration]

Вторичные конечные точки (12)

• Area under the concentration-time curve (AUC) [Срок оценки: Up to 7 days after the last administration]
• Peak plasma concentration [Срок оценки: Up to 7 days after the last administration]
• Time to peak concentration [Срок оценки: Up to 7 days after the last administration]
• Clearance (CL) [Срок оценки: Up to 7 days after the last administration]
• Apparent volume of distribution (V) [Срок оценки: Up to 7 days after the last administration]
• Half-life (T1/2) [Срок оценки: Up to 7 days after the last administration]
• Incidence of anti-drug antibodies (ADA) [Срок оценки: Up to 7 days after the last administration]
• Incidence of neutralizing antibodies (NAb) (if applicable) [Срок оценки: Up to 7 days after the last administration]
• Objective response rate (ORR) [Срок оценки: Through study completion, up to 2 years]
• Duration of response (DoR) [Срок оценки: Through study completion, up to 2 years]
• Tisease control rate (DCR) [Срок оценки: Through study completion, up to 2 years]
• Time to response (TTR) [Срок оценки: Through study completion, up to 2 years]

Критерии участия

Inclusion Criteria：

• Participants must be able to understand and sign the written informed consent form for participation in this trial, including all evaluations and procedures specified in this protocol.
• Male or female participants aged ≥18 years and ≤75 years.
• Participants with histologically or cytologically confirmed advanced small cell lung cancer.
• At least one measurable lesion according to RECIST V1.1 within 28 days prior to the first dose of IBI115.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival period ≥12 weeks.
• Adequate bone marrow and organ function confirmed during the screening period.

Exclusion Criteria：

• Concurrent participation in another interventional clinical study, except for observational non-interventional studies or being in the survival follow-up phase of an interventional study.
• Administration of a live vaccine within 4 weeks prior to the first dose of the study drug or a cancer vaccine within 3 months prior, or planning to receive any live vaccine during the study period.
• Adverse reactions from prior anti-tumor therapy that have not resolved to CTCAE v6.0 Grade 0, Grade 1, or baseline levels by the time of the first dose of the study drug.
• Known hypersensitivity or intolerance to IBI115, sintilimab, or any of their excipients.

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

• the second affiliated hospital of AMU — Чунцин

Идентификаторы

NCT: NCT07559019 · CIBI115A101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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