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.

Shanghai YingLi Pharmaceutical Co. Ltd.0 sites140 target enrollmentDecember 30, 2020

ConditionsFollicular Lymphoma

InterventionsYY-20394

DrugsYY-20394

Overview

Phase: Phase 2
Intervention: YY-20394
Conditions: Follicular Lymphoma
Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.
Enrollment: 140
Primary Endpoint: Overall response (OR)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

December 30, 2020

End Date

December 30, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai YingLi Pharmaceutical Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is ≥18 years of age at the time of signing the informed consent. Type of Patient and Disease Characteristics
•Has histologically confirmed follicular non-Hodgkin's lymphoma Grade ≤3 according to the WHO 2017 classification system.
•Has radiographically measurable disease as per Lugano Criteria with at least one nodal lesion (which has not been previous radiated) that is \>15 mm in long axis, regardless of the length of the short axis, AND/OR extranodal lesion of \>10 mm in long and short axis.
•Has received at least two prior lines of systemic therapy (excluding radiation) for follicular lymphoma. Refractory disease is defined as persistence of evaluable disease after therapy with documented disease progression at the time of enrollment.
•Must have relapsed (experienced disease progression) during their last follicular lymphoma regimen after receiving at least two cycles of therapy or within 12 months after completing their last regimen for follicular lymphoma.
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
•Has a life expectancy \>3 months.
•Has adequate organ function as defined in Table 5
•Specimen for this assessment must be collected within 14 days prior to the first dose of study treatment:
•Patient is male or female.

Exclusion Criteria

•Has follicular lymphoma histological Grade \>3 or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
•Has presence of central nervous system (CNS) disease (either CNS lymphoma or leptomeningeal lymphoma) that is clinically uncontrolled or diagnosed within 4 months of enrollment.
•Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
•Note: During the treatment period, patients should not take medication that may prolong the QT (such as antiarrhythmic drugs).
•Has peripheral neuropathy that is ≥Grade 2 with pain.
•Has a medical history of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the study treatment.
•Has diarrhea of CTCAE Grade \>
•Has a history of or concurrent interstitial lung disease of any severity and/or severely impaired lung function.
•Prior history of drug-induced colitis or drug-induced pneumonitis.
•Has a systemic infection or other serious infection requiring systemic treatment within 14 days before the first dose of study treatment.

Arms & Interventions

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.

Intervention: YY-20394