Phase I/II, First-in-Human, Dose-Escalation Study of X-396 in Patients with Advanced Solid Tumors and Expansion Phase in Patients with ALK+ Non-Small Cell Lung Cancer

This is the first human study to use X-396, a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide early information on how the body handles the drug (pharmacokinetics) and on the efficacy of X-396.

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy. Patients may have received prior crizotinib and/or second generation ALK TKIs. -For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations positive by FISH or IHC testing done centrally; however, patients will be allowed to enroll based on local ALK FISH or IHC results.
Phase I/II
Rachel Sanborn, M.D.
Brenda Fisher
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Westside