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A Study of LP-168 in Participants With Relapse or Refractory Mantle Cell Lymphoma

Primary Purpose

Mantle Cell Lymphoma (MCL)

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
LP-168
Sponsored by
Guangzhou Lupeng Pharmaceutical Company LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma (MCL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL. At least one measurable lesion. Subjects who have previously received the treatment regimen containing anti-CD20 and at least one BTKi treatment failed or relapsed after remission or intolerated; Or Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-CD20. ECOG≤2. Adequate hematologic function. Adequate hepatic and renal function. Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] or surgically sterile) to observe conventional and effective birth control. Exclusion Criteria: Received non-covalent BTK inhibitor treatment. Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of LP-168: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy. Subjects who have received the following treatments within 2 weeks before the first dose of LP-168: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia. Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections. Disease affects the central nervous system. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.

Sites / Locations

  • Anhui provincial cancer hospitalRecruiting
  • The first affiliated hospital of Anhui medical universityRecruiting
  • Peking University Third HospitalRecruiting
  • Beijing Cancer HospitalRecruiting
  • The first affiliated hospital of Chongqing mediacal universityRecruiting
  • Fujian Cancer HospitalRecruiting
  • Fujian Medical university union hospitalRecruiting
  • The first affiliated hospital of Xiamen universityRecruiting
  • Gansu provincial cancer hospital
  • Sun Yat-sen University Cancer CenterRecruiting
  • Meizhou people'shospitalRecruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • The fourth hospital of Hebei medical universityRecruiting
  • Harbin First Hospital
  • Henan Cancer HospitalRecruiting
  • Henan provincial people's hospitalRecruiting
  • The first affiliated hospital of Zhengzhou universityRecruiting
  • Hunan cancer hospitalRecruiting
  • Jiangsu cancer hospitalRecruiting
  • Jiangsu province hospitalRecruiting
  • The first affiliated hospital of Nanchang universityRecruiting
  • The second hospital of dalian medical universityRecruiting
  • Shengjing hospital of China medical universityRecruiting
  • The first hospital of China medical university
  • Qilu hospital of Shandong universityRecruiting
  • Shandong Cancer Hospital
  • West China School of MedicineRecruiting
  • Tianjin Hematonosis HospitalRecruiting
  • Tianjin medical university cancer hospitalRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Affiliated hospital of hebei university
  • Beijing Boren HospitalRecruiting
  • Beijing Friendship hospital
  • The First Bethune Hospital of Jilin University
  • Sichuan Cancer HospitalRecruiting
  • The First People's Hospital of FoshanRecruiting
  • Nanfang Hospital, Southern Medical University
  • Sun Yat-sen Memorial Hospital
  • The First Affiliated Hospital of Soochow University
  • The first affiliated hospital of Wenzhou medical universityRecruiting
  • Hubei Cancer Hospital
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LP-168

Arm Description

Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated

Outcomes

Primary Outcome Measures

Overall Response Rate
To assess the anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).

Secondary Outcome Measures

Overall Response Rate
To assess the anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by investigator.
Complete remission rate
To assess the preliminary anti-tumor activity of LP-168 based on complete remission rate (CR) as assessed by investigator and IRC.
Progression Free Survival
To assess the preliminary anti-tumor activity of LP-168 based on Progression Free Survival (PFS) as assessed by investigator and IRC.
Overall survival
To assess the preliminary anti-tumor activity of LP-168 based on Overall survival (OS) as assessed by investigator and IRC.
Duration of Response (DOR)
To assess the preliminary anti-tumor activity of LP-168 based on Duration of response (DOR) as assessed by the Investigator and IRC.
Time to Response (TTR)
To assess the preliminary anti-tumor activity of LP-168 based on Time to response (TTR) as assessed by the Investigator and IRC.
Safety Assessment
To evaluate the safety of LP-168 by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
Maximum Observed Plasma Concentration (Cmax)
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of LP-168
Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t)
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) Of LP-168
Maximum Observed Plasma Concentration (Tmax)
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of LP-168
Half-life period (T1/2)
PK As Assessed By Time To Half-life period (T1/2) Of LP-168
Quality of life (QoL)
Quality of life Assessed By the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire (The total score ranges from 30 to126, Items 29 and 30 are scored from 1 to 7 points, and other items are scored from 1 to 4 points. Except for items 29 and 30, the higher value, the worse QoL.)

Full Information

First Posted
January 19, 2023
Last Updated
August 29, 2023
Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05716087
Brief Title
A Study of LP-168 in Participants With Relapse or Refractory Mantle Cell Lymphoma
Official Title
An Open Label, Single Arm, Multicenter Phase II Study of the Efficacy and Safety of LP-168 Monotherapy for Recurrent or Refractory Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is an open-label, single arm, multi-center Phase 2 study of oral LP-168 in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma (MCL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LP-168
Arm Type
Experimental
Arm Description
Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated
Intervention Type
Drug
Intervention Name(s)
LP-168
Other Intervention Name(s)
NWP-775
Intervention Description
Subjects to take LP-168 orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
To assess the anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
Time Frame
Up to 24 Months
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
To assess the anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by investigator.
Time Frame
Up to 24 Months
Title
Complete remission rate
Description
To assess the preliminary anti-tumor activity of LP-168 based on complete remission rate (CR) as assessed by investigator and IRC.
Time Frame
Up to 24 Months
Title
Progression Free Survival
Description
To assess the preliminary anti-tumor activity of LP-168 based on Progression Free Survival (PFS) as assessed by investigator and IRC.
Time Frame
Measured from the date of first dose of study drug to the date of earliest disease progression or death or last visit, and assessed up to 24 months.
Title
Overall survival
Description
To assess the preliminary anti-tumor activity of LP-168 based on Overall survival (OS) as assessed by investigator and IRC.
Time Frame
Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.
Title
Duration of Response (DOR)
Description
To assess the preliminary anti-tumor activity of LP-168 based on Duration of response (DOR) as assessed by the Investigator and IRC.
Time Frame
Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.
Title
Time to Response (TTR)
Description
To assess the preliminary anti-tumor activity of LP-168 based on Time to response (TTR) as assessed by the Investigator and IRC.
Time Frame
Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.
Title
Safety Assessment
Description
To evaluate the safety of LP-168 by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
Time Frame
From first dose of study drug to 28 days after last dose of study drug
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of LP-168
Time Frame
Up to 24 hours post dose
Title
Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t)
Description
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) Of LP-168
Time Frame
Up to 24 hours post dose
Title
Maximum Observed Plasma Concentration (Tmax)
Description
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of LP-168
Time Frame
Up to 24 hours post dose
Title
Half-life period (T1/2)
Description
PK As Assessed By Time To Half-life period (T1/2) Of LP-168
Time Frame
Up to 24 hours post dose
Title
Quality of life (QoL)
Description
Quality of life Assessed By the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire (The total score ranges from 30 to126, Items 29 and 30 are scored from 1 to 7 points, and other items are scored from 1 to 4 points. Except for items 29 and 30, the higher value, the worse QoL.)
Time Frame
Up to 24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL. At least one measurable lesion. Subjects who have previously received the treatment regimen containing anti-CD20 and at least one BTKi treatment failed or relapsed after remission or intolerated; Or Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-CD20. ECOG≤2. Adequate hematologic function. Adequate hepatic and renal function. Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] or surgically sterile) to observe conventional and effective birth control. Exclusion Criteria: Received non-covalent BTK inhibitor treatment. Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of LP-168: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy. Subjects who have received the following treatments within 2 weeks before the first dose of LP-168: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia. Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections. Disease affects the central nervous system. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhu, MD, PhD
Phone
86-010-88196596
Email
zj@bjcancer.org
First Name & Middle Initial & Last Name or Official Title & Degree
Yuqin Song, MD, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD, PhD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Anhui provincial cancer hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaiyang Ding
Facility Name
The first affiliated hospital of Anhui medical university
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingshu Zeng
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100089
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongmei Jing, M.D.
Phone
+861082265531
Email
hongmei_jing@163.com
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuqin Song
Phone
+861088196596
Email
SongYQ_VIP@163.com
Facility Name
The first affiliated hospital of Chongqing mediacal university
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoqiong Tang
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Yang
Facility Name
Fujian Medical university union hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhen Shen
Facility Name
The first affiliated hospital of Xiamen university
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhifeng Li
Facility Name
Gansu provincial cancer hospital
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Cui
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingqing Cai, M.D.
Phone
+862087342823
Email
caiqq@sysucc.org.cn
Facility Name
Meizhou people'shospital
City
Meizhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guowu Wu
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Peng
Facility Name
The fourth hospital of Hebei medical university
City
Shijia Zhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Liu
Facility Name
Harbin First Hospital
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ma
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keshu Zhou
Facility Name
Henan provincial people's hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zunmin Zhu
Facility Name
The first affiliated hospital of Zhengzhou university
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Facility Name
Hunan cancer hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhou
Facility Name
Jiangsu cancer hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianqiu Wu
Facility Name
Jiangsu province hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Xu
Facility Name
The first affiliated hospital of Nanchang university
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Li
Facility Name
The second hospital of dalian medical university
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuhua Sun
Facility Name
Shengjing hospital of China medical university
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Yang
Facility Name
The first hospital of China medical university
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojing Yan
Facility Name
Qilu hospital of Shandong university
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunyan Ji
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zengjun Li
Facility Name
West China School of Medicine
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Jiang
Facility Name
Tianjin Hematonosis Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhua Yi
Facility Name
Tianjin medical university cancer hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lanfang Li
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Yang
Facility Name
Affiliated hospital of hebei university
City
Baoding
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youchao Jia
Facility Name
Beijing Boren Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Hu
Facility Name
Beijing Friendship hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Wang
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujun Gao
Facility Name
Sichuan Cancer Hospital
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihui Zhang
Facility Name
The First People's Hospital of Foshan
City
Foshan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Zhao
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xutao Guo
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping Ma
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengming Jin
Facility Name
The first affiliated hospital of Wenzhou medical university
City
Wenzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Yu
Facility Name
Hubei Cancer Hospital
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huijing Wu
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaoxiang Wang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of LP-168 in Participants With Relapse or Refractory Mantle Cell Lymphoma

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