Background: ABTL0812 is an anticancer agent in clinical development with a novel mechanism of action. It inhibits the Akt/mTOR axis after binding to PPARs and subsequent induction of TRIB3, a pseudokinase that acts as a negative regulator of Akt. Preclinical studies have shown high efficacy in different tumor types including NSCLC, endometrial cancer, pancreatic cancer and neuroblastoma. ABTL0812 exhibits, efficacy in resistant models and synergy with chemotherapy while maintaining extremely low toxicity.

Methods: A phase Ib clinical trial with a 3 + 3 escalation design and an expansion phase was performed in patients with advanced solid tumors. Safety and tolerability were the main objectives of the trial. ABTL0812 pharmacokinetics (PK) was determined and the ratio between phosphorylated Akt and total Akt (pAkt/Akt) levels in...