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.
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