CStone Pharmaceuticals and Blueprint Medicines Initiate Phase 1b/2 Clinical Trial of Fisogatinib in Combination with CS1001 for Patients with Hepatocellular Carcinoma
This trial will assess the potential for two complementary treatment approaches – precision therapy and immuno-oncology therapy – to enhance anti-tumor activity in locally advanced or metastatic HCC. Discovered by
"The CStone collaboration has rapidly expanded our global development activities into the
"HCC is a particularly aggressive disease and
A Phase 1 dose-escalation study of CS1001 has been completed in
Liver cancer is the second leading cause of cancer-related deaths worldwide, with HCC accounting for most liver cancers. The highest incidence of HCC occurs in regions with endemic hepatitis B virus, including
About the Phase 1b/2 Clinical Trial of Fisogatinib in Combination with CS1001
The Phase 1b/2 clinical trial is an open-label study of fisogatinib in combination with CS1001 for the treatment of patients with locally advanced or metastatic HCC. The trial consists of two parts: a dose-escalation phase and a dose-expansion phase. The dose-escalation phase was designed to evaluate two doses of fisogatinib in combination with a fixed dose of CS1001. The objective of the dose-escalation phase is to identify the recommended Phase 2 dose that will be used in the dose-expansion phase.
Objectives of the trial include evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of the combination regimen. FGF19 expression will be determined at a central laboratory. The trial is designed to enroll approximately 50 patients across multiple sites in
Fisogatinib is an orally available, potent, irreversible inhibitor of FGFR4. Fisogatinib was specifically designed by
CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based
CS1001 has completed a Phase 1 dose-escalation study in
CS1001 is being investigated in a number of ongoing clinical trials, including one Phase 1 bridging study in the U.S. In
Blueprint Medicines is a precision therapy company striving to improve human health. With a focus on genomically defined cancers, rare diseases and cancer immunotherapy, we are developing transformational medicines rooted in our leading expertise in protein kinases, which are proven drivers of disease. Our uniquely targeted, scalable approach empowers the rapid design and development of new treatments and increases the likelihood of clinical success. We are currently advancing three investigational medicines in clinical development, along with multiple research programs. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans and timelines for the development of fisogatinib, including the timing, design, implementation, enrollment, plans and announcement of results regarding
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