Clinical trial · Interventional
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
NCT02048709CI-TRIAL-00025805completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDC-0919 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GDC-0919 Dose Escalation
- 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
- interventionNames
- Drug: GDC-0919
Primary outcomes (3)
- measure
- Percentage of patients with dose-limiting toxicities
- timeFrame
- 28 days
- measure
- Number of dose-limiting toxicities
- timeFrame
- 28 days
- measure
- Percentage of patients with adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNayak-Kapoor A, Hao Z, Sadek R, Dobbins R, Marshall L, Vahanian NN, Jay Ramsey W, Kennedy E, Mautino MR, Link CJ, Lin RS, Royer-Joo S, Liang X, Salphati L, Morrissey KM, Mahrus S, McCall B, Pirzkall A, Munn DH, Janik JE, Khleif SN. Phase Ia study of the indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor navoximod (GDC-0919) in patients with recurrent advanced solid tumors. J Immunother Cancer. 2018 Jun 20;6(1):61. doi: 10.1186/s40425-018-0351-9. PMID 29921320