A Phase I/IIa Open-label Multi-centre Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of AZD0022 Monotherapy and in Combination with Anti-cancer Agents in Participants with Tumours Harbouring a KRASG12D Mutation (ALAFOSS-01)

Brief description of study

This study is a trial to test the tolerability, side effects, and early effectiveness of the drug AZD0022 in patients with advanced tumors that have a KRAS G12D mutation. The trial has three parts. In Part A, doctors will find the highest dose of the drug that causes few side effects. In Part B, they will figure out the best dose to use from part A. In Part C, they will see how well the drug works against cancer. The main goals are to see how many side effects happen, how well the drug works, and how the drug acts in the body.


Clinical Study Identifier: s24-01051
ClinicalTrials.gov Identifier: NCT06599502
Principal Investigator: Kristen Spencer.
Other Investigators: Nila Theresa De La Rosa, Scot Niglio, Samantha VanMaanen, Nancy Chan, Anam Qureshi, Jessica Wang, Kathleen M Madden, Elaine Shum, Carol M Lee, Jonathan B Kahn, Janice Mehnert, Joshua K Sabari, Keriann M Scavone, Salman Rafi Punekar, Nina Beri, Paul E. Oberstein, Maya Dimitrova, Kirby Rodriguez, Eneil De La Pena, Douglas K Marks, David R. Wise.


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