DS-3078a will be evaluated as a single agent in subjects with advanced solid tumor malignancies or lymphomas refractory to standard treatment or for which no standard treatment is available.
This is a Phase 1, open-label study of DS-3078a to assess safety and tolerability, identify the maximum tolerated dose (MTD) and tentative recommended phase 2 dose (RP2D), and assess pharmacokinetic and pharmacodynamic properties in subjects with advanced solid tumor malignancies or lymphomas. The study will include 2 parts: Dose Escalation and Dose Expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
DS-3078a will be administered as oral capsules once daily and will be supplied in 5, 20, 50, and 150 mg capsules.
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Maximum tolerated dose
To determine the maximum tolerated dose (MTD) and tentative recommended Phase 2 dose (RP2D) of DS 3078a
Time frame: 3 years
determine the Cmax profile of DS 3078a
determine the Cmax (maximum concentration) of DS-3078a administered under fed and unfed conditions
Time frame: 3 years
effect on glucose metabolism
determine the effect of DS-3078a on glucose metabolism by measuring serum glucose and C peptide
Time frame: 3 years
assess pharmacodynamic effects tumor glucose uptake
assess the pharmacodynamic effects of DS 3078a by determining tumor glucose uptake using (18F) fluorodeoxyglucose positron emission tomography (FDG-PET)
Time frame: 3 years
assess tumor response
assess tumor response to DS-3078a in subjects with advanced non-Hodgkin lymphomas or advanced solid tumor types in which the mammalian target of rapamycin (mTOR) signaling pathway is frequently activated
Time frame: 3 years
assess pharmacodynamic effects v-akt murine thymoma viral oncogene
assess the pharmacodynamic effects of DS 3078a by measuring v-akt murine thymoma viral oncogene homolog 1 (Akt) phosphorylation in platelet rich plasma (PRP)
Time frame: 3 years
determine the AUC of DS 3078a
determine the Area under the concentration versus time curve (AUC) of DS-3078a administered under fed and unfed conditions
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Time frame: 3 years
determine the Tmax of DS 3078a
determine the time of maximum concentyration (Tmax) of DS-3078a administered under fed and unfed conditions
Time frame: 3 years
determine the terminal half-life of DS 3078a
determine the terminal half-life (T1/2) of DS-3078a administered under fed and unfed conditions
Time frame: 3 years