AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K Mutation

Brief description of study

This trial is designed to test the effectiveness of ALTA2618 in patients with advanced solid tumors that have a specific genetic mutation (AKT1 E17K). The study is divided into two parts: Phase 1, where the dose of ALTA2618 will be increased to find the maximum safe dose, and Phase 1b, where the drug will be tested in different groups of patients with specific types of cancer, like HR+/HER2-negative breast cancer and gynecological cancers. The trial will also look at how the drug works in the body (pharmacokinetics), its effect on the tumor, and how safe it is at different doses. In Phase 1, patients will receive the drug once daily, and the dose will be adjusted based on the safety and effectiveness data collected during the study. If patients show positive results, they may continue treatment even after the disease progresses. The study will continue until the best dose and treatment schedule are determined for further testing in Phase 2 trials.


Clinical Study Identifier: s24-01275
ClinicalTrials.gov Identifier: NCT06533059
Principal Investigator: Nancy Chan.
Other Investigators: Nila Theresa De La Rosa, Elaine Shum, Scot Niglio, Cindy Corbo, Nitish Mehta, Danielle Seidman, Kirby Rodriguez, Maria Francis, Fabia Brisard Pierrot, Laura Palazzolo, Mariam M Cheaib, Salman Rafi Punekar, Jonathan B Kahn, Janice Mehnert, Joshua K Sabari, Keriann M Scavone, Marissa Rybstein, Nina Beri, Rajwanth Veluswamy, Paul E. Oberstein, Eneil De La Pena, Kathleen M Lutz, David R. Wise, Jessica Wang, Michelle Diane Swanson Lightfoot, Emeline Mariam Aviki, Carol M Lee, Allison Most, Jeffrey G Schneider, Amanda Marie Buzolich, Anastasiya Apanasyuk, Alexander A Hindenburg, Zujun Li, Victoria Helen Dowd, Samantha VanMaanen, Kelly A Levine, Edward A Jimenez, Kristen Spencer, Kathleen M Madden, Bhavana Pothuri, Matthew A. Ingham, Douglas K Marks.


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