A phase I clinical study of F-1515 in combination with F-1520 in patients with somatostatin receptor positive, progressive pancreatic, gastrointestinal, or pulmonary neuroendocrine tumors

FUJIFILM Toyama Chemical Co., Ltd. (Former FUJIFILM RI Pharma Co., Ltd.)1 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年1月22日

试验速览

暂无简介。

•Histopathological diagnosis of NET of the pancreas, gastrointestinal tract, or lung.
•Patients must have metastatic or locally advanced disease not amenable to curative resection.
•Tumor progression confirmed within 12 months before enrollment.
•Presence of at least one measurable disease as defined by RECIST.
•Accumulation of 111In-pentetreotide in all target lesions exceeding the accumulation in the normal liver documented by whole-body planar imaging.

•History of systemic treatment with any antineoplastic agents (excluding somatostatin analogs) within 8 weeks before enrollment.
•History of any surgery, radiofrequency ablation, (chemo)embolization, or radioembolization within 12 weeks before enrollment.
•History of peptide receptor radionuclide therapy (PRRT) even once.
•History of external radiation therapy covering >= 25% bone marrow.
•Patients currently receiving treatment with somatostatin analog who are expected to have difficulty in temporarily discontinuing the treatment for a defined period before each dose of F-1515.

Safety, tolerability, pharmacokinetics and dosimetry

of F-1515 administered as a single dose in combination with F-1520 infusion

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发起方

FUJIFILM Toyama Chemical Co., Ltd. (Former FUJIFILM RI Pharma Co., Ltd.)

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