The protein, p53, is responsible for stopping cellular growth and inducing the self-destruction of unwanted cells. As a result, the gene encoding for p53, TP53, is classified as a tumor suppressor gene. Proteins such as MDM2 and MDMX can inhibit p53, allowing for uncontrolled cellular growth. Abnormally high levels of these proteins have been found in breast cancer. ALRN-6924 is a drug that disrupts the interaction between p53 and MDMX and MDM2, allowing p53 to function properly as a tumor suppressor. Preclinical studies have found ALRN-6924 in combination with paclitaxel, a chemotherapy, had a synergistic effect against breast cancer cells. This phase I study will establish the safety of ALRN-6924 in combination with paclitaxel in patients with advanced or metastatic solid tumors without a functional mutation in TP53.
Trial Registration: ClinicalTrials.gov Identifier: NCT03725436