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

June 11, 2024 updated by: Shanghai YingLi Pharmaceutical Co. Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • Hematology Hospital of the Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai YingLi Pharmaceutical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YY-20394-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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