Beijing, China-based Avistone Biotechnology is planning to initiate a Phase I trial investigating PLB-1004 in patients with non-small cell lung cancer (NSCLC) in the US. The study is expected to start in H2 2023, chief business officer David Chung told Clinical Trials Arena.

PLB-1004 is a novel mono-anilino-pyrimidine small molecule that inhibits EGFR and targets exon 20 insertion. The drug also targets classical EGFR mutations such as ExDel19, L858R and T790M.

Avistone is currently in the IND filling process and is planning to enrol around 40-90 patients with EGFR exon 20 mutation. The exact number will depend on the number of doses studied and the US Phase I trial will be a two-part study comprising dose escalation and dose expansion.

The primary endpoint will look at the safety profile of PLB-1004 and measure a variety of different efficacy measures as secondary endpoints. The exact number of sites is yet to be determined, but Avistone estimates opening five US sites for the dose escalation portion, and 15 sites for the expansion part.

The Phase I trial in the US will have some trial design similarities to the ongoing Phase I trial in China. However, Avistone is planning to investigate a narrower dose range. The Phase I trial in China evaluated different regimens of PLB-1004, spanning from 10mg to 480mg once-daily doses and 160mg twice-daily doses.

Earlier in April, Avistone presented positive interim data from the Phase I trial in China. PLB-1004 was safe and well-tolerated. Chung said that the full dataset is expected at the end of 2023 or early 2024. Avistone opened seven sites in China for this Phase I trial.

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Further clinical development

Avistone also started a Phase II NSCLC trial in China with a focus on a specific patient profile. Chung explains that the Phase I trial had a mixed population of patients with EGFR-sensitive mutations, EGFR exon 20 insertion mutations and HER2 exon 20 insertions.

In the Phase II trial, Avistone is looking at the primary population of EGFR exon 20 insertion mutations in second-line post-platinum-based chemotherapy subjects. The primary endpoint will measure the overall response rate. The Phase II trial is expected to be completed in 2028.

Aside from PLB-1004, Avistone is planning to initiate trials in China and the US to evaluate ANS01 this year. ANS01 is a next-generation cMET inhibitor that is under development in both countries. The biotech also filed for China’s National Medical Products Administration’s (NMPA) approval for PLB-1001, another cMET inhibitor, in MET exon 14 skipping alterations.