A Phase I Study of GDC-0919 for Adult Patients With Recurrent Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- GDC-0919
- Conditions
- Solid Tumor
- Sponsor
- Genentech, Inc.
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Percentage of patients with dose-limiting toxicities
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
GDC-0919 Dose Escalation
GDC-0919 to be given on an outpatient basis as a single agent. Starting dose of GDC-0919 will be 50 mg by mouth every 12 hour. Patients will receive the study drug daily for 21 days followed by 7 days off for a cycle length of 28 days; or on 28 consecutive days of a 28-day cycle
Intervention: GDC-0919
Outcomes
Primary Outcomes
Percentage of patients with dose-limiting toxicities
Time Frame: 28 days
Number of dose-limiting toxicities
Time Frame: 28 days
Percentage of patients with adverse events
Time Frame: approximately 15 months
Secondary Outcomes
- Pharmacokinetics: Serum concentrations (Cmax/Steady State)(21 days)