New Delhi: Glenmark Pharma said the first patient has been dosed in a phase-1 clinical trial of GBR 1342, an investigational antibody for the treatment of multiple myeloma.
In May this year, the US health regulator had cleared Glenmark Pharma’s investigational new drug application to initiate phase-1 study of GBR 1342.
GBR 1342 is an investigational new drug from the company’s immuno-oncology portfolio.
“This first-in-human, open-label study’s primary objective is to assess the safety and tolerability of increasing doses of GBR 1342 in multiple myeloma patients until a maximum tolerated dose is reached,” Glenmark Pharma said in a BSE filing.
The additional study objectives include assessment of biomarkers, immunogenicity and additional measures of anti- tumour activity, it added.
“Glenmark is committed to a new model of drug discovery that emphasises quality and a highly efficient approach to clinical development, and this milestone for GBR 1342 is an example of this approach in action,” Glenmark Pharmaceuticals President and Chief Medical Officer Fred Grossman said.