Bridge Biotherapeutics has obtained authorisation from the US Food and Drug Administration (FDA) for commencing a first-in-human trial of BBT-207 to treat non-small cell lung cancer (NSCLC).

The proposed Phase l/ll trial will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity of BBT-207 in advanced NSCLC patients harbouring epidermal growth factor receptor (EGFR) mutation post EGFR tyrosine kinase inhibitor (TKI) treatment.

It will be carried out in dose escalation, recommended Phase ll dose selection and dose expansion phases.

During the trial, BBT-207 will be given orally throughout a 21-day cycle in each phase.

The trial is set to enrol up to 92 patients. It is anticipated to be conducted in around 15 sites in the US and South Korea.

In the dose escalation phase of a Phase la trial, Bridge expects to determine the recommended dose range (RDR) based on the toxicity/tolerability, efficacy, PK and PD profiles of BBT-207.

The Phase la trial also intends to detect BBT-207’s safety and tolerability based on treatment-related adverse events (AEs) and others.

As part of a Phase lb study, Bridge will choose the recommended Phase ll dose (RP2D) on the basis of PK, PD, objective response rate (ORR), duration of response (DOR), and the overall safety profile.

During the dose expansion stage, Phase ll preliminary antitumor activity of BBT-207 will be examined based on RECIST Version 1.1. 

Bridge Biotherapeutics founder and CEO James Lee said: “We’re excited to initiate the clinical development of BBT-207 in order to address the unmet medical needs of NSCLC patients.

“With this approval, the company will continue to focus on developing novel treatment options for late-stage lung cancer patients suffering from third-generation EGFR TKI resistance.”