A Molecularly Driven Phase 1b Dose Escalation and Dose Expansion Study of the DNA-PK Inhibitor Peposertib (M3814) in Combination with the ATR Inhibitor M1774

Brief description of study

This study tests the effectiveness of two drugs, peposertib (M3814) and M1774, in patients with advanced solid tumors who have certain genetic changes or signs of DNA stress. The study has two parts: first, a phase to find the highest dose with few side effects (maximum tolerated dose, or MTD), and second, to test the most effective dose (recommended Phase 2 dose, or RP2D) in more detail. In the dose escalation phase, groups of patients will receive different doses, and doctors will check for serious side effects over a 28-day period to decide if the dose should go up, stay the same, or go down. The expansion phase will have two groups: one for patients with ATM gene mutations and another for patients with signs of DNA replication stress, to study how the drugs affect these specific markers. The final dose chosen will aim for a side effect rate close to 25%, based on safety data. Rules are in place throughout the study to adjust doses and keep patients safe.


Clinical Study Identifier: s24-00271
ClinicalTrials.gov Identifier: NCT05687136
Principal Investigator: Nancy Chan.
Other Investigators: Nila Theresa De La Rosa, Elaine Shum, Danny Perlaza, Scot Niglio, Cindy Corbo, Yoke Wah Khoo, Danielle Seidman, Kirby Rodriguez, Janice Mehnert, Maya Dimitrova, Mariam M Cheaib, Jessica Wang, Joshua K Sabari, Keriann M Scavone, Marissa Rybstein, Nina Beri, Alexander A Hindenburg, Eneil De La Pena, Kathleen M Lutz, David R. Wise, Salman Rafi Punekar, Michelle Diane Swanson Lightfoot, Fabia Brisard Pierrot, Amanda Marie Buzolich, Marilyn Huang, Anastasiya Apanasyuk, Victoria Helen Dowd, Samantha VanMaanen, Bhavana Pothuri, Maria Francis, Edward A Jimenez, Kristen Spencer, Kathleen M Madden, Kelly A Levine, Rafael Winograd, Matthew A. Ingham, Douglas K Marks.


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.