NCT04379167

A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Follicular Lymphoma

A Phase 2, Single Arm, Open Label Clinical Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of YY-20394 in Patients With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma Who Have Failed at Least Two Prior Systemic Therapies.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2, single arm, open label clinical study to evaluate the efficacy, safety, tolerability and pharmacokinetics of YY-20394 as monotherapy in patients with relapsed/refractory follicular non-Hodgkin's lymphoma who have failed at least two prior systemic therapies

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	YY-20394	YY-20394 is a selective inhibitor of the delta isoform of phosphatidylinositol 3 kinase (PI3K-δ) which differs structurally from idelalisib, a PI3K-δ inhibitor approved for patients with relapsed chronic lymphocytic leukemia and indolent lymphoma. PI3K-δ signaling pathways are frequently hyperactive in B-cell cancers, making inhibition of PI3K-δ a promising target for B-cell malignancies. YY 20394 has high potency against PI3K-δ, but with markedly improved selectivity in in vitro assays compared to idelalisib. This higher selectivity for PI3K-δ may decrease the risk of serious infection seen with idelalisib and duvelisib (a PI3K-γ/δ dual inhibitor) due to strong immune suppression.

Timeline

• Start date: 2020-12-30
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2020-05-07
• Last updated: 2020-05-07

Regulatory

• FDA-regulated drug study