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

August 29, 2023 updated by: Guangzhou Lupeng Pharmaceutical Company LTD.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jun Zhu, MD, PhD
  • Phone Number: 86-010-88196596
  • Email: zj@bjcancer.org

Study Contact Backup

  • Name: Yuqin Song, MD, PhD

Study Locations

  • China
      • Baoding, China
        • Not yet recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
          • Youchao Jia
      • Beijing, China
        • Not yet recruiting
        • Beijing Friendship Hospital
        • Contact:
          • Zhao Wang
      • Beijing, China
        • Recruiting
        • Beijing Boren Hospital
        • Contact:
          • Kai Hu
      • Changchun, China
        • Not yet recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
          • Sujun Gao
      • Chengdu, China
        • Recruiting
        • Sichuan Cancer hospital
        • Contact:
          • Zhihui Zhang
      • Foshan, China
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
          • Ying Zhao
      • Guangzhou, China
        • Not yet recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Xutao Guo
      • Guangzhou, China
        • Not yet recruiting
        • Sun Yat-sen Memorial Hospital
        • Contact:
          • Liping Ma
      • Suzhou, China
        • Not yet recruiting
        • The First Affiliated Hospital Of Soochow University
        • Contact:
          • Zhengming Jin
      • Wenzhou, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Kang Yu
      • Wuhan, China
        • Not yet recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Huijing Wu
      • Wuhan, China
        • Recruiting
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Gaoxiang Wang
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Qingshu Zeng
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
          • Kaiyang Ding
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, Beijing, China, 100089
        • Recruiting
        • Peking University Third Hospital
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • The first affiliated hospital of Chongqing mediacal university
        • Contact:
          • Xiaoqiong Tang
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Yu Yang
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Jianzhen Shen
      • Xiamen, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Zhifeng Li
    • Gansu
      • Lanzhou, Gansu, China
        • Not yet recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
          • Jie Cui
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Meizhou, Guangdong, China
        • Recruiting
        • Meizhou people'shospital
        • Contact:
          • Guowu Wu
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Zhigang Peng
    • Hebei
      • Shijia Zhuang, Hebei, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
          • Lihong Liu
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China
        • Not yet recruiting
        • Harbin First Hospital
        • Contact:
          • Jun Ma
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Keshu Zhou
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Lei Zhang
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Zunmin Zhu
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Hui Zhou
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Wei Xu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
          • Jianqiu Wu
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Fei Li
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
          • Xiuhua Sun
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Wei Yang
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Contact:
          • Xiaojing Yan
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Chunyan Ji
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Zengjun Li
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China School of Medicine
        • Contact:
          • Ming Jiang
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Hematonosis Hospital
        • Contact:
          • Shuhua Yi
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Hospital
        • Contact:
          • Lanfang Li
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Haiyan Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL.
  2. At least one measurable lesion.
  3. 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.
  4. ECOG≤2.
  5. Adequate hematologic function.
  6. Adequate hepatic and renal function.
  7. 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:

  1. Received non-covalent BTK inhibitor treatment.
  2. 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.
  3. 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.
  4. Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.
  5. Disease affects the central nervous system.
  6. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LP-168
Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated
Drug: LP-168
Subjects to take LP-168 orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.
Other Names:
  • NWP-775

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Up to 24 Months
To assess the anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
Up to 24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Up to 24 Months
To assess the anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by investigator.
Up to 24 Months
Complete remission rate
Time Frame: Up to 24 Months
To assess the preliminary anti-tumor activity of LP-168 based on complete remission rate (CR) as assessed by investigator and IRC.
Up to 24 Months
Progression Free Survival
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.
To assess the preliminary anti-tumor activity of LP-168 based on Progression Free Survival (PFS) as assessed by investigator and IRC.
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.
Overall survival
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.
To assess the preliminary anti-tumor activity of LP-168 based on Overall survival (OS) as assessed by investigator and IRC.
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.
Duration of Response (DOR)
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.
To assess the preliminary anti-tumor activity of LP-168 based on Duration of response (DOR) as assessed by the Investigator and IRC.
Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.
Time to Response (TTR)
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.
To assess the preliminary anti-tumor activity of LP-168 based on Time to response (TTR) as assessed by the Investigator and IRC.
Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.
Safety Assessment
Time Frame: From first dose of study drug to 28 days after last dose of study drug
To evaluate the safety of LP-168 by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
From first dose of study drug to 28 days after last dose of study drug
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to 24 hours post dose
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of LP-168
Up to 24 hours post dose
Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t)
Time Frame: Up to 24 hours post dose
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
Up to 24 hours post dose
Maximum Observed Plasma Concentration (Tmax)
Time Frame: Up to 24 hours post dose
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of LP-168
Up to 24 hours post dose
Half-life period (T1/2)
Time Frame: Up to 24 hours post dose
PK As Assessed By Time To Half-life period (T1/2) Of LP-168
Up to 24 hours post dose
Quality of life (QoL)
Time Frame: Up to 24 Months
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.)
Up to 24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Lupeng Pharmaceutical Company LTD.

Investigators

  • Study Chair: Jun Zhu, MD, PhD, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 28, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP-168-CN201

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

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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