A Study of Anti-PD-1 and LAG-3 Bispecific Antibody(AK129) Combined With Chemotherapy With or Without Cadonilimab in the First-line Treatment of Unresectable Locally Advanced or Metastatic G/ GEJ Adenocarcinoma

Официальное название

A Phase Ib/II Open Label,Dose Escalation and Dose Extension Study Evaluating the Safety, Tolerability, and Initial Antitumor Efficacy of Anti-PD-1 and Lymphocyte Activation Gene 3(LAG-3) Bispecific Antibody AK129 Combined With Chemotherapy With or Without Cadonilimab in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Negative Unresectable Locally Advanced or Metastatic G/GEJ Adenocarcinoma

Обзор

Phase Ib/II clinical study of AK129 combined with chemotherapy with or without cadonilimab in first-line treatment of advanced HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma

Вмешательства

• Препарат Drug: AK129 Drug：oxaliplatin Drug：capecitabine
  AK129 is administered intravenously according to the frequency every three weeks(Q3W) and different dosage of administration at different stages.Oxaliplatin is administered intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice daily on day 1 to 14 Q3W.
• Препарат Drug: AK129 Drug：cadonilimab Drug：oxaliplatin Drug：capecitabine
  AK129 is administered intravenously according to the frequency Q3W and different dosage of administration at different stages. Cadonilimab is administered intravenously according to the frequency and dosage 10mg/kg Q3W.Oxaliplatin is administered intravenously according to the frequency and dosage 130 mg/m2 on day 1 Q3W.Capecitabine is administered intravenously according to the frequency and dosage 1000 mg/m2 oral twice daily on day 1 to 14 Q3W.

Первичные конечные точки

• Incidence and severity of adverse events(AE) [Срок оценки: Up to approximately 2 years]
• Incidence of serious adverse events(SAE) and suspected unexpected serious adverse reactions(SUSAR) [Срок оценки: Up to approximately 2 years]
• Incidence of dose-limiting toxicity(DLT) [Срок оценки: Up to approximately 2 years]
• Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension [Срок оценки: Up to approximately 2 years]
• Objective Solution Rate (ORR) based on RECIST v1.1 [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (7)

• Disease control rate(DCR) [Срок оценки: Up to approximately 2 years]
• duration of response(DoR) [Срок оценки: Up to approximately 2 years]
• time to response(TTR) [Срок оценки: Up to approximately 2 years]
• progression-free survival(PFS) [Срок оценки: Up to approximately 2 years]
• overall survival(OS) [Срок оценки: Up to approximately 2 years]
• Serum AK129, cadonilimab concentration, blood concentration-time curve and derived PK argument [Срок оценки: Up to approximately 2 years]
• Number and percentage of subjects with anti-drug antibodies (ADA) for AK129 and cadonilimab [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• The subject must sign the written informed consent form(ICF) voluntarily.
• Aged ≥ 18 to ≤ 75 years,male and female at the time of signing the ICF.
• Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction (GEJ).
• Inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
• Participants had not previously received systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
• According to RECIST v1.1 criteria, subjects had at least one measurable tumor target.

Критерии исключения

• Subjects with known HER2 positive gastric or gastroesophageal junction adenocarcinoma.
• Histopathological examination confirmed other pathological types.
• Had received palliative local therapy for non-target lesions within 2 weeks before the first administration.
• Past treatment with immune checkpoint inhibitors,immune checkpoint agonists,immune cell therapy and any treatment targeting the immune mechanism of tumor action.
• History of gastrointestinal perforation and fistula within 6 months before the first dose.
• Active or previously documented inflammatory bowel disease,inability to swallow, malabsorption syndrome.
• Active malignancy within the last 3 years.
• Active or untreated brain metastases, meningeal metastases, spinal cord compression, or pia meningeal disease are known to exist.
• The presence of clinical symptoms of pleural effusion, pericardial effusion, or abdominal effusion, or the need for frequent drainage.
• There was an active autoimmune disease that required systemic treatment within 2 years prior to the start of the study.

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

• Zhejiang Cancer Hospital — Hanzhou

Идентификаторы

NCT: NCT06586294 · AK129-103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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