ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Официальное название

A Phase Ib/Ⅱ Clinical Study to Evaluate the Safety and Efficacy of ANO31905 for Injection in Combination With Chemotherapy as the First-line Treatment for Patients With CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Обзор

The goal of this clinical trial is to assess the safety and efficacy of ANO31905 in combination with chemotherapy as the first-line treatment for subjects with CLDN18.2-positive locally advanced unresectable or metastatic pancreatic cancer.

Вмешательства

• Биопрепарат ANO31905
  The initial dose is 500 μg/kg Q2W. The drug will be administered on D1/D15 of each cycle. The maximum duration of administration is tentatively set at 2 years.
• Биопрепарат ANO31905
  ANO31905: If the lower dose is tolerated, a higher dose of 800 μg/kg will be administered to the subjects. ANO31905 will be administered on D1/D15 of each cycle. The maximum duration of administration is tentatively set at 2 years.
• Препарат Nanoparticle Albumin-Bound Paclitaxel
  125 mg/m\^2, intravenous infusion, D1/D8/D15 per cycle until PD, intolerable toxicity, or other discontinuation criteria specified in the protocol (whichever occurs first).
• Препарат Gemcitabine
  1000 mg/m\^2, intravenous infusion, D1/D8/D15 per cycle until PD, intolerable toxicity, or other discontinuation criteria specified in the protocol (whichever occurs first).

Первичные конечные точки

• Dose-limiting toxicity (DLT) (Phase Ib). [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
• Objective response rate (ORR) assessed by the investigator according to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1) (Phase Ⅱ) [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

• Males or females aged ≥ 18 at the time of signing the ICF;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Expected survival ≥ 3 months;
• Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;
• At least one measurable lesion according to RECIST v1.1;
• Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory;
• Patients with sufficient organ function within 7 days before the first study dose;
• Non-pregnant or -lactating women.

Критерии исключения

• Patients with other malignant tumors except pancreatic adenocarcinoma within 5 years before the first dose of the study treatment; Any previous systematic anti-cancer therapy
• Any previous systematic anti-cancer therapy;
• Previous treatment targeting CLDN18.2;
• Patients with a history of active autoimmune disorders or autoimmune disorders requiring systemic treatment;
• Patients with known hypersensitivity to any component or excipient of ANO31905, gemcitabine, and nanoparticle albumin-bound paclitaxel;
• Patients with known metastases to the central nervous system;
• Patients with severe cardiovascular and cardiovascular diseases;
• Presence risks of thrombosis or bleeding;
• Patients who have received attenuated live vaccines within 28 days before the first study dose or are expected to receive attenuated live vaccines during study treatment;
• Patients with gastrointestinal diseases that are not suitable for enrollment as judged by the investigator;
• Patients with other conditions that may place the patients at increased undue study-related risks.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• California Research Institute — Los Angeles

Идентификаторы

NCT: NCT07444541 · ANO31905-204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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