A Open-Label, Multiple Ascending Dose Study of DS-3078a, an Oral TORC1/2 Kinase Inhibitor, in Subjects With Advanced Solid Tumors or Lymphomas

History of primary central nervous system malignancies

Gastrointestinal diseases that could affect the absorption of DS-3078a in the opinion of the Investigator

Subjects with a fasting glucose \>126 mg/dL (\>7 mmol/L)

History of diabetes mellitus (type 1 or 2) or glycosylated hemoglobin \>7.0% at screening

Positive test for hepatitis B surface antigen or hepatitis C antibody

Recipient of live vaccine within 1 month of or during study drug treatment

Use of chronic systemic corticosteroids (use of nasal or inhaled steroids is permitted)

Subjects requiring daily supplemental oxygen

Recipient of an allogenic stem cell or bone marrow transplant

Presence of a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor

Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.

Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v4 grade =\<1 or baseline.

Systemic treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 3 weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment; or treatment with small-molecule targeted agents within 2 weeks or 5 half-lives before study drug treatment, whichever is longer.

Therapeutic radiation or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment

Participation in a clinical study within 3 weeks (2 weeks or 5 half-lives, whichever is longer, for small-molecule targeted agents) before study drug treatment, or current participation in other investigational procedures

Concomitant treatment with strong inhibitors or inducers of cytochrome P450 3A4 and P glycoprotein

Less than 1 week since using systemically acting drugs that increase gastric pH, such as H2-blockers and proton pump inhibitors. Antacids should be avoided within 48 hours of the first dose of DS 3078a

Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is \>450 msec based on triplicate electrocardiogram (ECG)

Pregnant or breastfeeding

Substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study results

For Part 2

Subjects who have had prior treatment with an mTOR catalytic site inhibitor or dual PI3K/mTOR inhibitor (including, but not limited to, OSI-027, INK128, ADZ8055,AZD2014, WYE12513, PP242, BEZ-235, DS-7423, XL765, GDC-0980, SF1126, GSK2126458, PF4691502, and PF05212384) will be disqualified from entering the study.

What this study is about