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H3B-6527 Demonstrates Tolerability in Phase I Trial for Patients With Advanced HCC

Martin E. Gutierrez, MD
Published Online:7:49 PM, Thu July 18, 2019

Martin E. Gutierrez, MD, director, Drug Discovery/Phase I Unit, and co-chief and medical oncologist, Divisions of Thoracic Oncology and Gastrointestinal Oncology, John Theurer Cancer Center, Hackensack University Medical Center, discusses the early findings for H3B-6527, an FGFR4 inhibitor, as a treatment of patients with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC).

At the 2019 ASCO Annual Meeting, Gutierrez presented data for the first-in-human phase I trial of H3B-6527 in patients with advanced HCC or ICC. Gutierrez says that FGFR4 can enhance tumor growth in HCC and ICC and is a rational target for treatment in this patient population.

In this dose-escalation trial, 17 of the 23 patients enrolled in the dose-escalation trial had Child-Pugh A, advanced HCC and were previously treated with a tyrosine kinase inhibitor and/or immunotherapy. H3B-6527 was administered in doses from 300 mg to 1000 mg.

The adverse effects were well tolerated, says Gutierrez. There were no dose-limiting toxicities. The most common treatment-related adverse events included diarrhea, nausea, and vomiting. Based on these safety findings, 1000 mg was the recommended dose for phase II.

With H3B-6527, investigators also started to see some responses and durable stable disease in the patients with HCC, Gutierrez concludes. This drug demonstrates potential for a patient population of unmet need.
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