This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase and an expansion phase.
Name: DCC-2618
Description: 50 mg formulated tabletsType: DrugExpansion Cohort 1 Expansion Cohort 10 Expansion Cohort 2 Expansion Cohort 3 Expansion Cohort 4 Expansion Cohort 5 Expansion Cohort 6 Expansion Cohort 7 Expansion Cohort 8 Expansion Cohort 9
Name: DCC-2618
Description: 10 mg and 50 mg formulated tabletsType: DrugEscalation
Description: Dose limiting toxicities, AEs, SAEs, discontinuation of drug due to toxicity, physical exams and ECOG PS, ophthalmologic examinations, changes from baseline in laboratory parameters, electrocardiograms, LVEF, and vital signs.
Measure: Safety/tolerability of oral DCC-2618: incidence of adverse events Time: Approximately 24 monthsDescription: Objective response rate (ORR); Disease control rate (DCR)
Measure: Expansion Phase: Assess Antitumor Activity of DCC-2618 in all diseases Time: Approximately 24 monthsDescription: Objective response rate (ORR); Disease control rate (DCR)
Measure: Escalation Phase: Assess Antitumor Activity of DCC-2618 in patients with advanced malignancies Time: Approximately 24 monthsAllocation: Non-Randomized
Parallel Assignment
There are 2 SNPs
Patients with de novo imatinib resistant mutations, such as but not limited to KIT D816V or PDGFRA D842V, are eligible without prior imatinib therapy. --- D816V ---
Patients with de novo imatinib resistant mutations, such as but not limited to KIT D816V or PDGFRA D842V, are eligible without prior imatinib therapy. --- D816V --- --- D842V ---