Aga Khan University Hospital in Nairobi has initiated a clinical trial to assess the efficacy of GDC-6036, a novel cancer drug developed by Roche Pharmaceuticals, targeting the KRAS gene. The study aims to determine whether the drug can safely and effectively prevent the KRAS gene from mutating into KRAS G12C, a variant associated with the development of lung, colon, and other cancers.
Targeting KRAS Mutations in Cancer
The KRAS gene, present in all cells, plays a crucial role in regulating cell division by relaying external signals to the cell nucleus. According to Prof. Mansoor Saleh, Director of the Clinical Research Unit at Aga Khan, uncontrolled activation of KRAS can lead to uncontrolled cell growth and potentially cancer. The trial focuses on blocking the KRAS G12C mutation, which is a key driver in several cancer types.
Trial Design and Patient Participation
The clinical trial involves at least 40 participants, including patients like Olivia, a Stage 3 breast cancer patient from Nairobi. Olivia expressed her hope that the trial would not only benefit her but also other women facing similar diagnoses. The trial is designed to monitor the safety and adverse events in patients across different phases, ensuring the drug's tolerability and effectiveness.
Importance of African Clinical Trials
Prof. Saleh emphasized the significance of conducting clinical trials in Africa to develop therapies that are more responsive to the genetic specifications of African populations. He noted that the metabolism of certain drugs can differ between Caucasian and African patients, highlighting the need for localized clinical research. Currently, only a small percentage of cancer-related clinical trials in Africa are conducted in countries with predominantly Black patients.
Challenges and Future Directions
Despite the critical need for clinical research in Africa, several factors hinder the scaling up of trials, including the lack of established clinical trial units, willingness to participate, and regulatory hurdles. In Kenya, where approximately 42,000 new cancer cases are recorded annually, with 27,000 cancer-related deaths, increased investment in clinical research is essential. If successful, GDC-6036 could represent a significant advancement in precision oncology, offering new treatment options for cancer patients based on their genetic profiles.