Clinical Trial of CBL0137

CBL0137 is an innovative small molecule oncology drug that interferes with a novel molecular target, FACT (Facilitates Chromatin Transcription) complex resulting in NF-kB suppression, Heat Shock Factor 1 suppression and p53 activation.


CBL0137 underwent preclinical studies in the Russian Federation and the USA and shown antitumor activity in the following subcutaneous human xenografts: colon adenocarcinoma, renal cell carcinoma, human non-small cell lung cancer, mammary gland adenocarcinoma and etc.


In April, 2 2012 The Ministry of Health of the Russian Federation granted permission №847 to conduct a Phase 1b, Multicenter, Multiple dose escalation study of CBL0137 oral administration in patients with advanced solid tumors.


The primary objective of the study is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of CBL0137 in patients with progressive solid tumors. Secondary objectives of the study include describing the safety profile, researching PK characteristics and antitumor activity of CBL0137. The study is being conducted in 5 clinical centers in Russia.


In parallel, a Phase 1, dose-escalation trial assessing the intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid neoplasms is ongoing in 3 US clinical centers. In 2013, this clinical trial was approved by the FDA.


Also, in both ongoing Phase 1 clinical trials the effect of CBL0137 on potential biologic markers is being evaluated in peripheral blood mononuclear cells.

A study of CBL0137 safety and efficacy in hematological malignancies is planned.

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