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A Single-Arm, Open-Label, Multi-Center, Phase Ib Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
A single-arm, open, multicenter study to investigate the efficacy and safety of YY-20394, an oral small molecular inhibitor of PI3K-delta, in patients with relapsed or refractory peripheral T cell lymphoma.
Details
| Lead sponsor | Shanghai YingLi Pharmaceutical Co. Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 58 |
| Start date | 2020-03-30 |
| Completion | 2021-12 |
Conditions
- Relapsed or Refractory Peripheral T-Cell Lymphoma
Interventions
- YY-20394
Primary outcomes
- ORR — up to 12 months
Objective Response Rate - DCR — up to 12 months
Disease control rate - Safety and Tolerability — up to 12 months
safety and tolerability of investigational product assessed as the number of participants experiencing adverse events (AEs, CTCAE5.0) or abnormalities in vital signs, laboratory tests, or electrocardiograms.
Countries
China