Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors

A Phase I Study of GDC-0919 for Adult Patients With Recurrent Advanced Solid Tumors

This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.

Inclusion Criteria:

• Histologically or cytologically confirmed solid tumor that is relapsed/refractory to standard therapies or for which no approved or curative therapy exists
• Age > or = 18
• Eastern Cooperative Oncology Group (ECOG) performance status < 2
• Life expectancy > or = 12 weeks
• Adequate hematologic and organ function before initiation of GDC-0919
• For some patients only: Accessible lesions amenable to paired fresh tumor biopsies

Exclusion Criteria:

• Some prior cancer immunotherapies
• Untreated brain metastases
• Active or history of autoimmune disease