Reporter Yoon So-young, biospectator
‘BBT-176’ is administered by three domestic institutions for patients with advanced non-small cell lung cancer.. Plan to enter a dose expansion trial in Korea and the United States within this year
Bridgebio therapeutics announced on the 7th that the administration of patients with phase 1/2 clinical trials of’BBT-176′, a candidate anticancer drug targeting lung cancer, began on the 2nd in three domestic institutions.
BBT-176 is a fourth generation EGFR mutant TKI (Tyrosine Kinase Inhibitor) targeting C797S epidermal growth factor receptor (EGFR) mutation. The C797S mutation is an acquired resistance mutation that appears after treatment with’Tagrisso, Osimertinib’, a third-generation EGFR-mutant TKI drug in non-small cell lung cancer (NSCLC).
According to Bridgebio, this clinical trial targets patients with locally advanced or metastatic non-small cell lung cancer with EGFR mutations. It plans to identify patient group data according to various mutations, such as Liquid Biopsy, which analyzes tumor cell mutations through oncogenes in the blood.
Bridgebio plans to conduct a Dose Escalation Study of BBT-176 first in Phase 1/2 clinical trial. The safety and tolerability of the drug is evaluated to determine the recommended phase 2 dose.
Next, in the Dose Expansion Study planned to be conducted in Korea and the United States this year, ▲ objective response rate (ORR) according to version 1.1 of the solid cancer response evaluation criteria (RECIST), ▲ response duration (DoR) ▲ progression-free survival ( PFS) will be evaluated. It covers approximately 90 patients and plans to evaluate the antitumor activity of BBT-176 in certain EGFR mutation types.
Lee Jung-gyu, CEO of Bridge BioTherapeutics, said, “We are very proud to be the first to start clinical trials of BBT-176, a new anticancer drug targeting C797S mutant non-small cell lung cancer, in Korea, with no treatment options worldwide.”
Meanwhile, detailed information related to the BBT-176 clinical trial can be found in the Clinical Trial Information menu in the website of the Integrated Drug Information System of the Ministry of Food and Drug Safety.