SKB500 Combinations in Patients With Small Cell Lung Cancer

Официальное название

A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Small Cell Lung Cancer

Обзор

The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.

Вмешательства

• Препарат SKB500 Powder for Injection
  SKB500 will be administered as an intravenous (IV) infusion, every 3 weeks on Day 1 of each 21-day cycle and the dose will be determined based on the efficacy and safety data from the SKB500-I-01 study.
• Препарат KL-A167 Injection
  KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)
• Препарат Carboplatin Injection
  Carboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle（AUC 5, Cycles 1-4)
• Препарат Etoposide Injection
  Etoposide will be administered as an intravenous (IV) infusion every 3 weeks on Day 1, 2, and 3 of each 21-day cycle (100 mg/m\^2, Cycles 1-4).

Первичные конечные точки

• Incidence and severity of adverse events (AEs) [Срок оценки: up to 24 months]
• Progression-free survival (PFS) [Срок оценки: up to 24 months]

Вторичные конечные точки (7)

• Objective Response Rate (ORR) [Срок оценки: up to 24 months]
• Duration of response (DOR) [Срок оценки: up to 24 months]
• Disease control rate (DCR) [Срок оценки: up to 24 months]
• Overall Survival (OS) [Срок оценки: up to 24 months]
• Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB500-ADC, SKB500-TAB and free payload [Срок оценки: Cycle 1-4, 6, 8,12,16, every 8 cycles starting from Cycle 16 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months]
• Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB500-ADC, SKB500-TAB and free payload [Срок оценки: Cycle 1-4, 6, 8,12,16, every 8 cycles starting from Cycle 16 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months, up to 24 months]
• Anti-drug Antibodies (ADA) for SKB500 [Срок оценки: Cycle 1-4, 6, 8, 12, 16, every 8 cycles starting from Cycle 16 Day 1: pre-dose, (each cycle is 21 days), up to 24 months]

Критерии участия

Критерии включения

• Male or female participants between 18 and 75 years old.
• Histologically or cytologically confirmed Extensive-stage small cell lung cancer (ES-SCLC):

• Cohort 1: participant has received or not received prior systemic treatment, with no more than 1 prior systemic therapy in the extensive stage.
• Cohort 2\~3: participant has received no prior systemic treatment.
• Agree to provide fresh or archival tumor tissue for biomarker analysis.
• Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy >= 12 weeks.
• Has adequate organ and bone marrow functions.
• Has recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.
• Effective contraceptive methods should be used during the study and for 6 months after the end of treatment.
• Voluntarily join this study, sign the informed consent form, and can comply with the protocol-specified visits and procedures.

Критерии исключения

• The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components.
• Has previously received medications with the same target or the same toxins.
• Presence of spinal cord compression or clinically active central nervous system metastases.
• Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels.
• Severe infection within 4 weeks or active infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose.
• With peripheral neuropathy of grade ≥ 2.
• History of any serious, life threatening, or permanently discontinuing adverse events mediated by immunotherapy, including infusion reactions.
• Presence of uncontrolled concurrent diseases, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Severe active peptic ulcer, gastrointestinal bleeding, gastrointestinal perforation, intestinal obstruction, etc.
• Serious or uncontrolled heart disease or clinical symptoms requiring treatment.
• History of interstitial lung disease (ILD) /noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis.
• Clinical severe lung damage caused by concurrent lung disease.
• Uncontrolled hypertension, diabetes, or repeated drainage of pleural effusion/pericardial effusion/ abdominal effusion.
• Pregnant or lactating women.
• Rapid disease deterioration in the screening process.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07296809 · SKB500-II-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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