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

NCT04279405 | Completed Phase 1

• 1 other identifier: YY-20394-007
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Lymphocytic Lymphoma; Lymphoplasmacytic Lymphoma; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (3)

• Adverse events evaluated by NCI CTCAE V5.0

  incidence of adverse events and associated dose of YY-20394

  Throughout the study for approximately 2 years

• Overall response rate

  the percentage of participants achieving a complete response or partial response

  Throughout the study for approximately 2 years

• disease control rate

  the percentage of participants achieving a complete response or partial response or stable disease

  Throughout the study for approximately 2 years

Study Arms (1)

YY-20394

EXPERIMENTAL

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

Drug: YY-20394

Interventions

YY-20394 DRUG

YY-20394 80mg tablet administered orally once daily

YY-20394

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai YingLi Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, China

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: June 15, 2020
• Primary Completion: September 30, 2021
• Study Completion: June 1, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

CN (1)