A Phase II Study of Linperlisib (YY-20394) in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma

NCT05274997 | Unknown Phase 2 FDA Drug

• 1 other identifier: YY-20394-012
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II, single-arm study to evaluate the efficacy, safety, and PK of oral linperlisib (YY-20394) monotherapy in adult patients with R/R Peripheral T/NK Cell Lymphoma. The study will be conducted at approximately 15 sites in United States.

Conditions

Peripheral T/NK Cell Lymphoma (R/R PTCL)

Outcome Measures

Primary Outcomes (1)

• overall response rate (ORR)

  Overall response rate (ORR = CR + PR), from start of treatment to first documented response, measured by Lugano 2014 Response Criteria for NHL (Cheson 2014)

  Throughout the study for approximately 2 years

Secondary Outcomes (11)

• duration of response (DOR)

  Throughout the study for approximately 2 years

• progression-free survival (PFS),

  Throughout the study for approximately 2 years

• Overall survival (OS)

  Throughout the study for approximately 2 years

• Time to response (TTR)

  Throughout the study for approximately 2 years

• AE

  Throughout the study for approximately 2 years

Study Arms (1)

YY-20394

EXPERIMENTAL

Administer linperlisib (YY-20394) 80 mg (4 tablets) orally with water, once daily, in a 28-day cycle.

Drug: YY-20394

Interventions

YY-20394 DRUG

Linperlisib is a strong and selective small-molecule PI3K-δ (a protein involves in the survival of cells) inhibitor, which is able to interfere with the growth, migration and survival of T/NK lymphoma cells.

Also known as: Linperlisib

YY-20394

Eligibility Criteria

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

You may qualify if:

• Adult patient ≥18 years of age at the time of signing the informed consent.
• Diagnosis of one of the following histologic subtypes of PTCL, pathologically confirmed, as defined by the WHO 2017 classification system:
• Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS)
• Angioimmunoblastic T-cell lymphomas (AITL)
• Anaplastic large cell lymphoma (ALCL). ALK positive or ALK negative
• Natural-killer/T-cell lymphoma (NKTCL)
• Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL).
• Has received and failed at least one line of systemic therapy.
• Not a candidate for autologous or allogeneic transplantation.
• For patients with CD30+ PTCL, progressed on or are ineligible or intolerant to brentuximab vedotin.
• Agree to provide archived tumor tissue samples or undergo pretreatment fresh tissue biopsy.
• Has radiographically measurable disease as per Lugano Criteria with at least one measurable disease lesion \> 1.5 cm in at least one dimension (which has not been previous radiated) by 18FDG-PET-CT, MRI, or diagnostic CT within 28 days prior to start of study treatment.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Has adequate organ function as defined below:
• System Laboratory Value Haematological Absolute neutrophil count

You may not qualify if:

• \. Patients with peripheral T-cell lymphoma having known central nervous system (CNS) invasion (either CNS lymphoma or leptomeningeal lymphoma).
• \. Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication, any other cardiac disorder not suitable for participation in this study based on the judgment of the investigator. Note: During the treatment period, patients should not take medication that may prolong the QT (such as antiarrhythmic drugs).
• \. Presence of multiple factors affecting drug administration and absorption such as inability to swallow, diarrhea of CTCAE Grade \>1, and ileus.
• \. Has a history of or concurrent interstitial lung disease of any severity and/or severely impaired lung function.
• \. Prior history of drug-induced colitis or drug-induced pneumonitis. 6. Has active viral, bacterial, fungal infection or other serious infection requiring systemic treatment within 14 days before the first dose of study treatment. Routine antimicrobial prophylaxis is permitted.
• \. Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.
• \. Use of therapeutic doses of warfarin sodium (Coumadin), or any other coumarin-derivative anticoagulants. The administration of low-molecular weight heparin is allowed.
• \. Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to CTCAE version 5.0 grade 0 or 1 with the exception of alopecia and peripheral neuropathy.
• \. Medical history of other primary malignant tumors in the past 5 years, or any evidence of residual disease from a previously diagnosed malignancy. Note: Exceptions are patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast, cervical cancer in situ, superficial bladder tumors \[Ta and Tis; carcinoma in situ\]) who have undergone curative therapy with no evidence of recurrence, localized prostate cancer previously fully resected undergoing surveillance or other adequately treated Stage 1 cancer currently in complete remission.
• \. Has received prior treatment with linperlisib (YY-20394), or other PIK3-δ inhibitors. Patients who have received prior treatment with other PIK3-δ inhibitors, but were intolerant to them, maybe included.
• \. Has received prior treatment with rituximab or other unconjugated antibody treatment within 28 days (21 days if clear evidence of progressive disease or immediate treatment is mandated) prior to the first dose of study treatment.
• \. Has received radioimmunoconjugates or toxin conjugates within 12 weeks before the first dose of study treatment.
• \. Has had received prior systemic anticancer therapy, or definitive radiotherapy ≤28 days (14 days for palliative radiation) prior to the first dose of study treatment.
• \. Has received prior targeted small molecule therapy ≤14 days or 5 half-lives whichever is longer.
• \. Has undergone major surgery (excluding lymph node biopsy) or significant trauma ≤4 weeks before the first dose of study treatment. Note: patients must have recovered adequately from surgery prior to starting study treatment.

Sponsors & Collaborators

• Shanghai YingLi Pharmaceutical Co. Ltd.: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Ranjit Nair, MD.

  MD Anderson, Houston TX 77030 Study Chair: Swaminathan P Iyer MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meiyue Hong

CONTACT

+862151370693; myhong@yl-pharma.com

Hanying Bao

CONTACT

+862151370693; hybao@yl-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 11, 2022
• Study Start: May 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)