A Phase 1a/1b Open-Label Study Evaluating the Safety Tolerability Pharmacokinetics and Efficacy of BBO-11818 in Subjects with Advanced KRAS Mutant Cancers

Brief description of study

This is a Phase 1 study testing whether the study medicine BBO-11818 (a pan-KRAS inhibitor) is safe and effective in patients with locally advanced solid tumors that have spread from their primary site to other parts of the body (metastatic) and show changes in the KRAS gene.

This study has two parts. Part I is called Phase 1a, where patients will be divided into groups. Group 1 will receive the study medication BBO-11818, and Group 2 will include patients with non-small cell lung cancer that shows specific changes of KRASG12D or KRASG12V in the KRAS gene. This group will receive BBO-11818 along with other standard chemotherapy medications, including pembrolizumab, Cisplatin, or carboplatin, and pemetrexed. Group 3 will receive a combination of BBO-11818 and cetuximab (an EGFR inhibitor) in patients with colorectal cancer showing specific changes of KRASG12D- or KRASG12V in the KRAS gene. The study team will gradually increase the doses of BBO-11818 across all groups to find out the most effective dose. Part 2, called Phase 1b, will enroll more patients to be grouped in the same way as in Part 1 to further examine the safety and effectiveness of the study medicine.

All patients will have regular check-up visits. Blood samples will be collected from all patients to see how their bodies are handling the study medicines, and routine laboratory tests will be done to check for their overall well-being. Specialized blood tests will be done to monitor for changes in DNA, RNA, and proteins (biomarkers) in response to the study treatment and to learn more about their cancer. Special scans will be done for all patients to check how the tumor size changes in response to the study treatment. The study team will monitor all patients for potential side effects and safety concerns.


Clinical Study Identifier: s25-00880
ClinicalTrials.gov Identifier: NCT06917079
Principal Investigator: Rajwanth Veluswamy.
Other Investigators: Kelly C O'Sullivan, Elaine Shum, Yoke Wah Khoo, David Mendoza, Eneil De La Pena, Shun Yu, Maya Dimitrova, Mariam M Cheaib, Jessica Wang, Manuel Hidalgo Medina, Shushma Upadhayay, Keriann M Scavone, Zefie Kanos, Joshua K Sabari, Natalia Cherkassky, Nina Beri, Paul E. Oberstein, David R. Wise, Salman Rafi Punekar, Michelle Diane Swanson Lightfoot, Jennifer Chuy, Samantha VanMaanen, Bhavana Pothuri, Daniel J Becker, Elise Roughan, Kristen Spencer, Kirby Rodriguez, Melissa L Martinez, Kathleen M Madden, Nancy Chan, Rafael Winograd, Ruth A White, Matthew A. Ingham, Kathleen M Lutz.


If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.