South Korea-based biotechnology company Bridge Biotherapeutics has begun a Phase I/II clinical trial of BBT-207 to treat non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
BBT-207 is a new epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that hinders the signalling pathway of EGFR with C797S mutations.
The open-label trial will assess the tolerability, safety and antitumour activity of BBT-207.
It is expected to enrol around 92 NSCLC patients who have previously been treated with a minimum of one third-generation EGFR TKI.
The trial will comprise a dose escalation section, a recommended Phase II dose selection (RP2D) stage and a dose expansion portion.
The recommended dose range will be determined in the Phase Ia dose escalation cohort.
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In the Phase Ib RP2D selection stage, the trial’s safety monitoring committee will determine the RP2D of BBT-207.
The Phase II dose expansion cohort will evaluate initial anti-tumour activity using the objective response rate.
According to preclinical research, BBT-207 demonstrated activity against treatment-emergent complex EGFR mutations with T790M and/or C797S and drug-naïve mutants.
Bridge Biotherapeutics CEO James Lee said: “We are highly encouraged to be able to initiate the first-in-patient study of BBT-207, which is expected to address unmet medical needs of advanced NSCLC patients with C797S mutations across the globe.”
Last month, Bridge Biotherapeutics discontinued development of a similar fourth-generation EGFR TKI, BBT-176, at the Phase Ia dose escalation part.
The company said it will remain committed to the development of a fourth-generation EGFR TKI while concentrating its capacity and financial resources on BBT-207.
Founded in 2015, Bridge Biotherapeutics is engaged in discovering and developing novel therapeutics for treatment areas with high unmet needs, including fibrotic diseases and cancers.
Earlier this year, the company reported data from a Phase IIa trial of BBT-401 for ulcerative colitis, which failed to meet its primary efficacy endpoints.