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

NCT04379167 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2020-05-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Shanghai YingLi Pharmaceutical Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2022-12-30
Completion
2022-12-30
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04379167 on ClinicalTrials.gov