A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors

Официальное название

A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS015 Combination Therapy in Patients With Advanced Solid Tumors

Обзор

This is a phase Ib/II, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JS015 combination therapy in patients with advanced solid tumors. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics and efficacy.

Вмешательства

• Биопрепарат JS015
  JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.
• Биопрепарат Toripalimab
  Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
• Биопрепарат Paclitaxel
  Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
• Препарат Irinotecan
  Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
• Препарат Capecitabine
  Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
• Препарат Oxaliplatin
  Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
• Биопрепарат Bevacizumab
  Bevacizumab of 5mg/kg will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or7.5mg/kg on day 1 every 21 day cycle, based on different combined chemotherapy.
• Препарат Fluorouracil
  Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
• Препарат Leucovorin
  Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
• Препарат Gemcitabine
  Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.

Первичные конечные точки

• incidence of dose-limiting toxicity （DLT） [Срок оценки: 2 Years]
• incidence of adverse event（AE） [Срок оценки: 2 Years]
• Recommended dose for phase II trial RP2D [Срок оценки: 2 Years]

Вторичные конечные точки (7)

• Peak concentration (Cmax) [Срок оценки: 2 years]
• time to peak concentration（Tmax） [Срок оценки: 2 years]
• elimination half life（t1/2） [Срок оценки: 2 years]
• immunogenicity [Срок оценки: 2 years]
• Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1) [Срок оценки: 2 years]
• Progression free survival (PFS) [Срок оценки: 2 years]
• overall survival (OS) [Срок оценки: 2 years]

Критерии участия

Критерии включения

1\. Patients who meet the following criteria for each indication cohort:

• Esophageal cancer cohort, patients with histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable or with distant metastasis, who progressed during or after prior first-line PD-(L)1 antibody and platinum-based chemotherapy;
• Gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with locally advanced unresectable or distant metastases, HER2-negative, who progressed during or after prior first-line PD-(L)1 antibody and platinum-based chemotherapy;
• 1L gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with HER2-negative results and no prior systemic antitumor therapy;
• Colorectal cancer cohort, patients with histologically confirmed adenocarcinoma of the colon or rectum, who progressed during or after first-line 5-FU-based combination therapy;
• Pancreatic cancer cohort, patients with histologically or cytologically confirmed locally advanced unresectable or distant metastatic pancreatic ductal adenocarcinoma, who have not received any previous systemic antitumor therapy 2 . Eastern Cooperative Oncology Group (ECOG) 0 or 1; 3. Life expectancy >=12 weeks; 4. At least one measurable lesion according to RECIST 1.1; 5. Adequate organ function;

Критерии исключения

• Leptomeningeal metastases and /or active brain metastases;
• Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated management (puncture, drainage, etc.);
• History of interstitial lung disease or a previous history of noninfectious pneumonia with corticosteroid therapy, or evidence of active pneumonia on screening imaging;
• History of immunodeficiency;
• History of serious cardiovascular and/or cerebrovascular diseases;
• History of abdominal or tracheo-esophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first dose of administration

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

• Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT06139211 · JS015-002-Ib/II-GI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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