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Intra-hepatic bile tube cancer (IHCC) is a cancer that develops in cells in the bile tube.
390,000 new cases a year in China, accounting for nearly 50% of the global annual incidence of liver cancer in 2018.
IHCC is the second most common primary malignant liver tumor, after hepatocellular carcinoma (HCC).
about 10-15% of IHCC patients have FGFR2 fused tumors.
long-term survival of IHCC patients is worse than that of HCC, which may be associated with a high propensity for regional and far-end metastasis and a lack of effective systemic treatment options.
HMPL?453 is a new, highly selective small molecule inhibitor for FGFR 1, 2 and 3.
in preclinical studies, HMPL?453 was more potency and better kinase selectivity than other similar drugs.
, Hutchison Whampoa has begun a Phase II clinical study of HMPL-453 for the treatment of IHCC.
the clinical study is a one-arm, multi-center, open-label Phase II study designed to assess the efficacy, safety, and pharmacodynamics of HMPL-453 in patients with advanced FGFR2 fusion IHCC who failed in at least one systematic treatment.
end points are objective response rate (ORR), and secondary endpoints include disease control rate (DCR), response time (DoR), progress-free lifetime (PFS), and overall lifetime (OS).
for additional details, please visit Clinicaltrials.gov (NCT04353375).
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