A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies

Shanghai Yingli Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Marginal Zone Lymphoma

Mantle Cell Lymphoma

Small Lymphocytic Lymphoma

Lymphoplasmacytic Lymphoma

Diffuse Large B Cell Lymphoma

Treatments

Drug: YY-20394

Study type

Interventional

Funder types

Industry

Identifiers

NCT04279405

YY-20394-007

Details and patient eligibility

About

Protocol YY-20394-007 is a phase1 open-label, single-arm, multi-centre study to assess the safety and efficacy of YY-20394 in participants with relapse and/or refractory B cell malignant hematological tumor. eligible participants will initiate oral therapy with YY-20394 at a starting dose of 80mg taken once per day. treatment with YY-20394 can continue in compliant participants as long as the study is still ongoing and the participants appear to benefiting from treatment with acceptable safety.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

histologically or cytologically confirmed relapse and/or refractory B cell hematologic malignancies(Excluding follicular lymphoma)
prior treatment with ≥1 prior standard anti-tumor regimens and 2 courses of treatments at least
eastern cooperative oncology group performance status of 0 to 2
life expectancy of at least 3 months
presence of >1.5cm radiographically measurable lymphadenopathy or extranodal lymphoid malignancy, and legibility in two vertical directions
acceptable organ functions
discontinuation of all other antitumor therapies before the first drug dose administration
for men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up six periods
willingness and ability to provide written informed consent and to comply with the protocol requirements

Exclusion criteria

prior therapy with PI3K-delta inhibitors（except the intolerable subjects）
the dosage of steroid hormone(predisone equivalent) was greater than 20mg/d, and lasted for more than 14 days
medical condition of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditional that may hamper compliance and/or absorption of the investigational product
concurrent drugs which maybe prolong the QT during the study period
subjects with central nervous system metastasis
Prior or current medical condition of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc
active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
known history of chronic active hepatitis B infection, chronic active hepatitis C
known history of immunodeficiency, including HIV positive test, other acquired or congenital immunodeficiency disorders, organ transplantation or allogeneic bone marrow transplantation
autologous hematopoietic stem cell transplantation was received within 90 days before the first dose administration
prior or ongoing heart disease, including: angina pectoris, clinically significant arrhythmia, myocardial infarction, heart failure, and any other heart disease judged by the researchers not eligible to the study
pregnancy or breastfeeding
prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant or impair the assessment of study results
receiving granulocyte colony-stimulating factor(GCSF) or blood transfusion within seven days before screening
history of a non-lymphoma malignancy except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ
subjects, in the opinion of the the Investigator, who are unsuitable to participate in the study for any other reason.