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

A Single-Arm, Open-Label, Multi-Center, Phase Ib Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T-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 cell lymphoma.

Study Overview

• Status: Unknown
• Conditions: Relapsed or Refractory Peripheral T-Cell Lymphoma
• Intervention / Treatment: Drug: YY-20394

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 1

Contacts and Locations

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

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 3000
      • Recruiting
      • Hematology Hospital of Chinese Academy of Medical Sciences

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:

1. Males and/or females over age 18
2. Histologically or cytologically confirmed diagnosis of relapsed or refractory peripheral T cell lymphoma.
3. Eastern Cooperative Oncology Group performance status of 0 to 2.
4. Life expectancy of at least 3 months.
5. At least one measurable lesion according to IRWG.
6. Adequate organ function.
7. Had anti-tumor treatments greater than or equal to 2 weeks prior to the first dose of investigational product (including TKI, chemotherapy, radiotherapy, immunotherapy and major surgery).
8. 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.
9. Volunteers did not participate in other clinical trials within 1 month prior to study entry.
10. Able to comply with the protocol judged by investigator.
11. Provision of signed and dated, written informed consent prior to any study- specific evaluation.

Exclusion Criteria:

1. Previous treatment with any PI3K-delta ihinibitors. 2. Uncontrolled pleural effusion and ascites. 3. the dosage of steroid hormone ( prednisone equivalent ) was greater than 20mg/day, and lasted for more than 14 days. 4. Medical conditions in swallowing, malabsorption, or other chronic gastrointestinal disease that may hamper compliance and/or absorption of the investigational agent. 5. During the study period, drugs that may prolong the QT (such as anti arrhythmic drugs) could not be interrupted. 6. Evidence of central nervous system involvement of the malignancy, including invasion of brain parenchyma and meninges, or spinal cord compression. 7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy(such as pneumonia). 8. Active infection with hepatitis B and C virus ( Volunteers with HBsAg or HBcAb positive and HBV-DNA greater than or equal to 1000 coRpies/ml or 200IU/ml; HCV antibody and HCV-RNA positive ). 9. History of immune deficiency ( acquired or congenital ), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation. 10. Presence of severe or uncontrolled cardiovascular disease. 11. The baseline pregnancy test was positive in pregnant women, lactating women or fertile women. 12. According to the judgement of the investigator, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (such as severe hypertension, diabetes, thyroid diseases, etc.). 13. Medical history of other primary malignant tumors in the past 5 years except for the following: clinically cured cervical in situ, local basal cell carcinoma of the skin.

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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; YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.	Drug: YY-20394; Each treatment cycle is comprised of 28-day consecutive of YY-20394, 80mg QD (days 1 to 28). Upon completion of each cycle, patients may continue to receive oral YY-20394 tablets if there 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
DCR	Disease control rate	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 (ACTUAL): March 30, 2020
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (ACTUAL): September 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

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, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: YY-20394-004

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