The objective of Part 1 is to assess the safety of DCC-3009 as monotherapy given at escalating doses and to characterize their PK, pharmacodynamic profile, and preliminary efficacy to select recommended doses and/or identify the MTD. The objective of the expansion is to evaluate the preliminary anticancer activity of DCC-3009 dose(s) selected from Part 1 in initially 1 expansion cohort (EA1) and possibly additional expansion cohorts in the future, and to further characterize the safety, PK, and pharmacodynamics of DCC-3009.

Who can Participate

-Have histologically or cytologically confirmed advanced or metastatic GIST with documented KIT or PDGFRA mutation. -Part 1: Have progressed on or are intolerant to at least 1 approved TKI-based regimen given in the advanced/metastatic setting (if KIT mutation, must have received imatinib). -Part 2: Have progressed on or are intolerant to 2 TKI-based regimens given in advanced/metastatic setting and who have not received additional systemic therapy for advanced/metastatic GIST (if KIT mutation, must have received imatinib). Progression within 12 months of completion of adjuvant therapy counts as 1 line of systemic therapy. Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov

Study ID

More information available at ClinicalTrials.gov: NCT06630234