drugset / Trial / NCT02903914
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
Non-randomizedFactorialOpen-labelTreatment
Summary
This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.
Timeline
- Start
- 2016-09-14
- Primary completion
- 2020-04-30
- Completion
- 2022-08-15
Publications
- Naing A, Papadopoulos KP, Pishvaian MJ, Rahma O, Hanna GJ, Garralda E, Saavedra O, Gogov S, Kallender H, Cheng L, Smith M, Chen X, Kuriakose E, Bauer T. First-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours. BMJ Oncol. 2024 May 9;3(1):e000249. doi: 10.1136/bmjonc-2023-000249. eCollection 2024.
- Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NUMIDARGISTAT | Small molecule | 50 mg | Oral |
| Subject | NUMIDARGISTAT | Small molecule | 75 mg | Oral |
| Subject | NUMIDARGISTAT | Small molecule | 100 mg | Oral |
| Subject | NUMIDARGISTAT | Small molecule | 150 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |