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

Genentech

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: GDC-0919

Study type: Interventional

Funder types: Industry

Identifiers

NCT02048709

NLG9191 (Other Identifier)

GO29753

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

GDC-0919 Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: GDC-0919