drugset / Trial / NCT04432857
AN0025 and Pembrolizumab Combination in Advanced Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, multicenter, phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled patients will be treated with AN0025 and Pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.
Timeline
- Start
- 2020-08-20
- Primary completion
- 2024-05-31
- Completion
- 2025-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PALUPIPRANT | Small molecule | — | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |