A Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma

A Single-arm, Open, Multicenter, Phase II Study to Investigate the Efficacy and Safety of YY-20394 in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma

A single-arm, open, multicenter study to investigate the efficacy and safety of YY-20394, an oral small molecular inhibitor of PI3K-delta, in patients with relapsed or refractory peripheral T/NK cell lymphoma.

Study Overview

• Status: Not yet recruiting
• Conditions: PTCL
• Intervention / Treatment: Drug: YY-20394 treatment

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yang Shu, MMeD; Phone Number: 86 21-58320003; Email: yshu@yl-pharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and/or females over age 18.
• Histologically or cytologically confirmed diagnosis of relapsed or refractory peripheral T/NK cell lymphoma.
• Eastern Cooperative Oncology Group performance status of 0 to 1.
• Life expectancy of at least 3 months.
• At least one measurable lesion according to Lugano 2014.
• Adequate organ function.
• Had anti-tumor treatment within 2 weeks prior to the first dose of investigational product (including TKI, Chinese herbal anti-tumor treatment); within 4 weeks prior to the first dose of investigational product (including chemotherapy, radiotherapy, immunotherapy and major surgery); other targeted therapies with 5 half-life period prior to the first dose.
• Men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose.
• Volunteers did not participate in other clinical trials within 1 month prior to study entry.
• Provision of signed and dated, written informed consent prior to any study- specific evaluation.

Exclusion Criteria:

• Previous treatment with any PI3K-delta inhibitors.
• Uncontrolled pleural effusion and ascites.
• The dosage of steroid hormone (prednisone equivalent) was greater than 20mg/day, and lasted for more than 14 days.
• Medical conditions in swallowing difficulty, malabsorption, or other chronic gastrointestinal disease that may hamper compliance and/ or absorption of the investigational agent.
• Drugs that may prolong the QT (such as anti-arrhythmic drugs) could not be interrupted during the study period.
• Evidence of central nervous system involvement of the malignancy, including invasion of brain parenchyma and meninges, or spinal cord compression.
• Have active viral, bacterial, fungal, or other infections that require systematic treatment (e.g., active tuberculosis), excluding nail bed fungal infections.
• Active infection with hepatitis B and C virus (volunteers with HBsAg or HBcAb positive but HBV-DNA negative, or HCV antibody positive but HCV-RNA negative can be enrolled).
• History of immune deficiency (acquired and congenital), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation; with active autoimmune disease or history of autoimmune disease (e.g., autoimmune enteritis and systemic lupus erythematosus).
• prior autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study drug.
• Presence of severe or uncontrolled cardiovascular disease.
• Medical history of active bleeding within 2 months prior to study entry, or currently achieved anticoagulant therapy, or susceptible to bleed by the judgement of investigator.
• Presence of concomitant diseases that are seriously endanger the safety of patient or affect the completion of the study by the investigator's judgment (e.g., uncontrolled hypertension, diabetes, thyroid diseases).
• Had received GCSF or blood transfusion treatment within 14 days prior to study entry.
• Female subjects of childbearing potential have a positive pregnancy test at the baseline.
• Medical history of other primary malignant tumors in the past 5 years except for the following: clinically cured cervical or breast carcinoma in situ, local basal cell or squamous cell carcinoma of the skin, thyroid tumor.
• Adverse events occurred during previous anticancer therapy have not been recovered to ≤1 (CTCAE 5.0) except toxicity with no significant risk determined by investigator such as alopecia.
• Live vaccine was administered within 30 days prior to the first dose of the investigational drug, or was scheduled to be administered during the study period.
• Judgment by the investigator that the volunteer should not participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: YY-20394 treatment; YY-20394 tablets, 20mg spec, 80mg QD, 28 days for each cycle.	Drug: YY-20394 treatment; Each treatment cycle is comprised of 28-day consecutive dosing of YY-20394, 80mg QD (days 1 to 28). Upon completion of each cycle, patients may continue to receive oral YY-20394 tablets if they are benefit from the treatment and the toxicity is tolerable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOR	Duration of response	up to 12 months
PFS	Progression free survival	up to 12 months
DCR	Disease control rate	up to 12 months
TTR	Time to response	up to 12 months
Safety and Tolerability	safety and tolerability of investigational Product assessed as the number of participants experiencing adverse events (AEs, CTCAE5.0) or abnormalities in vital signs, laboratory tests, or electrocardiograms.	up to 12 months

Collaborators and Investigators

• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (ACTUAL): January 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: YY-20394-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No