A Phase 1/2 First-in-Human Study of DCC-3116 as Monotherapy and in Combination with RAS/MAPK Pathway Inhibitors in Patients with Advanced or Metastatic Solid Tumors with RAS/MAPK Pathway Mutations

Brief description of study

This study is designed for patients who have Advanced or Metastatic Solid Tumors with RAS/MAPK Pathway Mutations

The objective of the study is to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of DCC-3116 as monotherapy and in combination with trametinib, or binimetinib or sotorasib in the Dose Escalation Phase (Part 1).

The purpose of Expansion Cohorts 1 through 3 in the Dose Expansion Phase (Part 2) is to demonstrate the antitumor activity of DCC-3116 combination with trametinib in RAS/MAPK pathway mutant tumors where autophagy has been implicated as a mechanism of resistance to MAPK pathway inhibitors such as the MEK inhibitor, trametinib.


Clinical Study Identifier: s22-00776
Principal Investigator: Janice Mehnert.
Other Investigators: Nila Theresa De La Rosa, Elaine Shum, Scot Niglio, Vamsidhar Velcheti, Maya Dimitrova, Jeffrey S. Weber, Salman Rafi Punekar, Jonathan B Kahn, Joshua K Sabari, Keriann M Scavone, Cosmin Adrian Tegla, Nina Beri, Avital Benson, Caitlin Elizabeth Ryan, David R. Wise, Jessica Wang, Carol M Lee, Sally Lau, Samantha VanMaanen, Kristen Spencer, Kathleen M Madden, Douglas K Marks.


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