An Open-label Phase 1 Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor activity of NT-112 in Human Leukocyte Antigen-C*08:02-Positive Adult Subjects with Unresectable Advanced and/or Metastatic Solid Tumors That Are Positive for the KRAS G12D Mutation

Brief description of study

This study is testing a NT-112, a type of cellular therapy, in patients with advanced cancer, such as lung, pancreatic, or colorectal cancer, who have a specific genetic change called KRAS G12D. The study team wants to see if the medicine has few side effects and is effective in treating the cancer. They will try different amounts of the medicine to find the highest dose that patients can handle without severe side effects. The researchers will carefully follow a plan to decide how much medicine each patient will get. The study team will keep a close eye on any side effects. The study has different periods, like screening, where they check if people meet the criteria, enrollment, treatment, and follow-up. Patients will go through various tests before joining the study, and the researchers will collect information about safety, effectiveness, and other factors.


Clinical Study Identifier: s23-01471
ClinicalTrials.gov Identifier: NCT06218914
Principal Investigator: Salman Rafi Punekar.
Other Investigators: Jaime Andres Suarez Londono, Nicole Karich, Elaine Shum, Rena Kandinova, Oscar B Lahoud, Scot Niglio, Jamie M Pavlonnis, Keriann M Scavone, Eneil De La Pena, Shun Yu, Marissa Hornacek, Kirby Rodriguez, Rafael C Singson, Amanda Marie Ferris, Anna C Hatzinikolaou, Jingmei Hsu, Joshua K Sabari, Mohammad Maher Abdul Hay, Nina Beri, Paul E. Oberstein, David R. Wise, Eileen Zhao, Sally Lau, Jennifer Chuy, Maureen E Musatto, Kelsey Stocker, Sejal Singh, Laura P. Diaz, Samantha VanMaanen, Daniel J Becker, Kristen Randolph Jordan, Jamie Robin Nemrow, Kristen Spencer, Chelsea F Curione, Kathleen M Madden, Nancy Chan, Rafael Winograd.


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