A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Follicular Lymphoma

NCT04379167 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: YY-20394-009
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase 2, single arm, open label clinical study to evaluate the efficacy, safety, tolerability and pharmacokinetics of YY-20394 as monotherapy in patients with relapsed/refractory follicular non-Hodgkin's lymphoma who have failed at least two prior systemic therapies

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response (OR)

  complete response (CR) or partial response (PR).

  throughout the study approximately 2 years

Secondary Outcomes (1)

• evaluate duration of response (DOR)

  throughout the study approximately 2 years

Other Outcomes (8)

• progression-free survival (PFS)

  throughout the study approximately 2 years

• Adverse events (AEs)

  throughout the study approximately 2 years

• AUClast

  throughout the study approximately 2 years

Study Arms (1)

YY-20394

EXPERIMENTAL

YY-20394 is a selective inhibitor of the delta isoform of phosphatidylinositol 3 kinase (PI3K-δ) which differs structurally from idelalisib, a PI3K-δ inhibitor approved for patients with relapsed chronic lymphocytic leukemia and indolent lymphoma.

Drug: YY-20394

Interventions

YY-20394 DRUG

YY-20394 is a selective inhibitor of the delta isoform of phosphatidylinositol 3 kinase (PI3K-δ) which differs structurally from idelalisib, a PI3K-δ inhibitor approved for patients with relapsed chronic lymphocytic leukemia and indolent lymphoma. PI3K-δ signaling pathways are frequently hyperactive in B-cell cancers, making inhibition of PI3K-δ a promising target for B-cell malignancies. YY 20394 has high potency against PI3K-δ, but with markedly improved selectivity in in vitro assays compared to idelalisib. This higher selectivity for PI3K-δ may decrease the risk of serious infection seen with idelalisib and duvelisib (a PI3K-γ/δ dual inhibitor) due to strong immune suppression.

YY-20394

Eligibility Criteria

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

You may qualify if:

• \- Age
• Patient is ≥18 years of age at the time of signing the informed consent. Type of Patient and Disease Characteristics
• Has histologically confirmed follicular non-Hodgkin's lymphoma Grade ≤3 according to the WHO 2017 classification system.
• Has radiographically measurable disease as per Lugano Criteria with at least one nodal lesion (which has not been previous radiated) that is \>15 mm in long axis, regardless of the length of the short axis, AND/OR extranodal lesion of \>10 mm in long and short axis.
• Has received at least two prior lines of systemic therapy (excluding radiation) for follicular lymphoma. Refractory disease is defined as persistence of evaluable disease after therapy with documented disease progression at the time of enrollment.
• Must have relapsed (experienced disease progression) during their last follicular lymphoma regimen after receiving at least two cycles of therapy or within 12 months after completing their last regimen for follicular lymphoma.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Has a life expectancy \>3 months.
• Has adequate organ function as defined in Table 5 1. Specimen for this assessment must be collected within 14 days prior to the first dose of study treatment:
• Patient is male or female.
• Male patients are eligible to participate if they agree to use a highly effective contraception as detailed in Appendix 4 of this protocol during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
• Female patient are eligible to participate if they are not pregnant (see Appendix 4), not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) as defined in Appendix 4. OR
• A WOCBP who agrees to use a contraceptive method that is highly effective (with a failure rate of \<1% per year), or be abstinent from heterosexual intercourse as their preferred method and usual lifestyle as described in Appendix 4, beginning 28 days before the start of study treatment, during the treatment period and for at least 3 months after the last dose of study treatment.
• A WOCBP must have a negative serum pregnancy within 72 hours of the first dose of study treatment.

You may not qualify if:

• Has follicular lymphoma histological Grade \>3 or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
• Has presence of central nervous system (CNS) disease (either CNS lymphoma or leptomeningeal lymphoma) that is clinically uncontrolled or diagnosed within 4 months of enrollment.
• 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.
• Note: During the treatment period, patients should not take medication that may prolong the QT (such as antiarrhythmic drugs).
• Has peripheral neuropathy that is ≥Grade 2 with pain.
• Has a medical history of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the study treatment.
• Has diarrhea of CTCAE Grade \>1.
• 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.
• Has a systemic infection or other serious infection requiring systemic treatment within 14 days before the first dose of study treatment.
• Has a known additional malignancy that is progressing or required active treatment within 2 years of enrollment.
• Note: 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 are not excluded.
• Prior/Concomitant Therapy
• Has received prior treatment with YY-20394, or other PIK3-δ inhibitors.
• 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.

Sponsors & Collaborators

• Shanghai YingLi Pharmaceutical Co. Ltd.: lead

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Hanying Bao, MD,PhD

CONTACT

86 21-51370693; 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: April 29, 2020
• First Posted: May 7, 2020
• Study Start: December 30, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After the clinical trail.
• Access Criteria: It will be updated later.