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Kenyan University Opens Clinical Trial Site for Roche's Investigational KRAS G12C Inhibitor

NEW YORK – The Aga Khan University Hospital in Nairobi, Kenya, has begun a clinical trial of Roche's investigational KRAS G12C inhibitor GDC-6036 in solid tumors.

GDC-6036 is a small molecule drug designed by Genentech, a member of the Roche Group, to selectively bind to a specific pocket of the protein and irreversibly lock it into an inactive state. In preclinical studies, the drug showed potent and selective inhibition of KRAS G12C-mutant cancers.

AKUH is the first site in Africa selected for the Phase Ib trial, in which Roche will evaluate the safety, pharmacokinetics, and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors bearing a KRAS G12C mutation. The trial is in line with the hospital's commitment to increase participation of African countries in global cancer trials. The World Health Organization estimates there are over 40,000 new cancer cases and more than 28,000 cancer-related deaths every year in Kenya.

"Research has found that there are genetic differences between the African population and the rest of the world. This means that we have to study novel treatments on our population for they may respond differently or have more or less toxicity than patients from the West," Mansoor Saleh, director of the Aga Khan University's Cancer Center and the AKUH Clinical Research Unit, said in a statement. "This is exactly the reason why we at Aga Khan University have made the conduct of clinical trials and the establishment of the clinical research unit our mandate." 

Genentech is also studying GDC-6036 and other drugs in a Phase II/III basket trial involving patients with unresectable, advanced, or metastatic non-small cell lung cancer driven by oncogenic mutations or tumor mutational burden.