Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a biopharmaceutical company, announced on Thursday that it has signed a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany.
The clinical trial collaboration and supply agreement has been signed for the combination therapy of IBI351 (GFH925) with cetuximab (ERBITUX(R)) as a potential frontline treatment for NSCLC patients with KRASG12C mutation in a Phase 1b clinical trial in China.
According to the contract, Innovent is carrying out a Phase 1b study to assess the anti-tumour activity and safety of the combination therapy of IBI351(GFH925) with cetuximab in Chinese subjects with advanced or metastatic NSCLC harbouring KRASG12C mutation.
Merck KGaA, Darmstadt, Germany is offering clinical drug supplies of cetuximab in this multi-centre trial in China.
Presently, the company is carrying out a single-arm registrational trial of IBI351(GFH925) monotherapy in earlier-treated advanced non-small cell lung cancer subjects with KRASG12C mutation in China, with expected NDA filing by the end of 2023. A Phase 1b study of IBI351(GFH925) along with sintilimab for earlier untreated advanced NSCLC subjects with KRASG12C mutation is also being tested.
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