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

Sponsor

Shanghai YingLi Pharmaceutical Co. Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04279405

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Small Lymphocytic Lymphoma Lymphoplasmacytic Lymphoma Marginal Zone Lymphoma Mantle Cell Lymphoma Diffuse Large B Cell Lymphoma	Drug: YY-20394	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1b Study to Assess the Safety and Efficacy of YY-20394 in Subjects With Recurrent and/or Refractory B-cell Hematologic Malignancies

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: YY-20394 treatment with YY-20394 will be continued until tumor progression or development of unacceptable toxicity.	Drug: YY-20394 YY-20394 80mg tablet administered orally once daily

Arm

Intervention/Treatment

Experimental: YY-20394

treatment with YY-20394 will be continued until tumor progression or development of unacceptable toxicity.

Drug: YY-20394

YY-20394 80mg tablet administered orally once daily

Outcome Measures

Primary Outcome Measures

Adverse events evaluated by NCI CTCAE V5.0 [Throughout the study for approximately 2 years]
incidence of adverse events and associated dose of YY-20394
Overall response rate [Throughout the study for approximately 2 years]
the percentage of participants achieving a complete response or partial response
disease control rate [Throughout the study for approximately 2 years]
the percentage of participants achieving a complete response or partial response or stable disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.