Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Follicular (FL) or Marginal Zone (MZL) Lymphoma

NCT ID: NCT04431089

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-09
• Study Completion Date: 2021-07-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of SHC014748M in patients with relapsed or refractory relapsed or refractory follicular (FL) or marginal one (MZL) lymphoma.

Detailed Description

This is a phase II, multicenter study to assess the efficacy and safety of SHC014748M, an oral inhibitor of PI3K delta, in patients with relapsed or refractory relapsed or refractory follicular (FL) or marginal one (MZL) lymphoma.

Conditions

Follicular Lymphoma(FL); Marginal Zone Lymphoma(MZL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHC014748M treatment

SHC014748M capsule, 200mg QD, 28 days for each cycle

Group Type: EXPERIMENTAL

SHC014748M

Intervention Type: DRUG

Each treatment cycle is comprised of 28-day consecutive dosing of SHC014748M, 200mg QD (Days 1 to28). Upon completion of each cycle, patients may continue to receive oral SHC014748M if they can benefit from the treatment and the toxicity is tolerable.

Interventions

SHC014748M

Each treatment cycle is comprised of 28-day consecutive dosing of SHC014748M, 200mg QD (Days 1 to28). Upon completion of each cycle, patients may continue to receive oral SHC014748M if they can benefit from the treatment and the toxicity is tolerable.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult, male and female volunteers, above 18 years of age inclusive.
• Histologically or cytologically confirmed diagnosis of relapsed or refractory FL(grade 1, 2 or 3a) and MZL, including splenic marginal zone lymphoma(SMZL), nodal marginal zone B cell lymphoma(NMZL) and mucosa associated lymphoid tissue(MALT) lymphoma. Relapse refers to disease progression after adequate treatment to remission；refractory refers to no remission after adequate treatment. The above "remission" includes complete remission and partial remission. Adequate treatment refers to two or more treatments with CD20 monoclonal antibody (CDE approved for marketing) combined with alkylation agent, including but not limited to bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan and nitrosoureas.
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
• Life expectancy ≥ 3 months.
• Patients have at least 1 measurable lesion that measures ≥1.5 cm in a single dimension as assessed by CT or MRI.
• Adequate organ function, as defined by the following values:ANC≥1.0×10^9/L； PLT≥50×10^9/L;Hb≥80 g/L;TBIL≤2×ULN(TBIL>2×ULN for subjects with Gilbert syndrome,TBIL>3×ULN for subjects with focal compression of bile duct judged by investigators); ALT and AST≤2.5×ULN(ALT and AST≤5×ULN for subjects with impaired liver function caused by hepatic infiltration);blood urea nitrogen(BUN) and Cr≤1.5×ULN;LVEF≥50%;QTcF <450 ms for male, QTcF <470 ms for female.
• 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, and female subjects of childbearing potential have a negative pregnancy test at baseline.
• Subjects 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 PI3Kδ inhibitors.
• Evidence of aggressive lymphoma(suspected clinical transformation should be conformed by biopsy).
• Had any other anti-tumor treatment within 4 weeks prior to screening(including radiotherapy, chemotherapy, Chinese herbal anti-tumor treatment and major surgery); targeted therapy with 5 half-life period prior to screening.
• Evidence of central nervous system involvement of the malignancy.
• Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, uncontrolled pleural effusion and ascites, uncontrolled diabetes, severe or debilitating lung disease.
• Any of the severe heart diseases, including New York Heart Association (NYHA) Class II or greater heart failure, arrhythmias requiring medical treatment, and history of myocardial infarction or unstable angina within 6 months prior to screening.Requiring any concomitant medication known to prolong the QT interval within 5 half-life period.
• Evidence of active bacterial, fungal, or viral infection, and need systemic treatment.
• Active infection with hepatitis B virus (HBV) (HBsAg positive, or HBsAg negative and HBV-DNA positive), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
• Concomitant use of any strong inhibitors or inducers of CYP3A4(except drug withdrawal prior to first dose of investigational drug.
• Use of granulocyte colony-stimulating factor(G-CSF) or blood transfusion within 7 days before the hematology test at screening.
• Prior autologous hematopoietic stem cell transplantation within 3 months prior to screening.
• 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 including Interstitial pneumonia, autoimmune enteritis, autoimmune hepatitis and systemic lupus erythematosus
• History of any uncured malignant tumor in the past five 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.
• Inability to swallow the drug, or history of diseases affecting gastrointestinal functions significantly including malabsorption syndrome,bariatric surgery,inflammatory bowel disease, partial or complete intestinal obstruction.
• Adverse events occurred during previous anticancer therapy have not been recovered to ≤1(CTCAE 5.0).
• History of hypersensitivity to the main composition or any inactive excipient of the study drug.
• Women who are breastfeeding.
• With alcohol or drug abuse disorder.
• History of stroke or intracranial hemorrhage with 6 months prior to screening.
• Attenuated live vaccination within 4 weeks prior to screening.
• With basic medical condition leading to risk of taking study drugs judged by investigators, or with confusion to toxicity and adverse events.
• Judgment by the investigator that the patient should not participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Sanhome Pharmaceutical, Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianyong Li, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chao Wang

Role: CONTACT

wangchao@sanhome.com

13851803148

Hongchan Zhang

Role: CONTACT

zhanghcyf@sanhome.com

15150516871

Facility Contacts

Jianyong Li, MD

Role: primary

Jie Jin, MD

Role: primary

Other Identifiers

SHC014-II-01

Identifier Type: -

Identifier Source: org_study_id