A Phase 1, Dose Escalation Study to Assess the Safety and Tolerability of ASP9853 With Either Docetaxel or Paclitaxel in Patients With Advanced Non-hematologic Malignancies

Inclusion Criteria

• •Subject must have a histologically or cytologically confirmed incurable, locally advanced, or metastatic non-hematologic malignancy that has progressed or failed to respond to regimens or therapies known to provide clinical benefit
• •Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• •Subject must have recovered from the effects of prior systemic antineoplastic or radiation therapy(s) to ≤ Grade 1 severity or to subject's baseline values, excluding alopecia
• •Subject agrees not to participate in another interventional study while on treatment
• •Female subject must be either:
• •Of non child bearing potential:
• •post-menopausal (defined as at least 1 year without any menses) prior to Screening or
• •documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)
• •Or, if of childbearing potential:
• •must have a negative serum pregnancy test at Screening and
• •must use two forms of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days after final study drug administration
• •Acceptable forms include:
• •Established use of oral, injected or implanted hormonal methods of contraception.
• •Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• •Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal
• •foam/gel/film/cream/suppository
• •Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final study drug administration.
• •Male subject must not donate sperm starting at Screening and throughout the study period and for 28 days after final study drug administration.
• •Subject with adequate bone marrow, renal, and hepatic function at baseline