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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

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