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

Mantle Cell Lymphoma (MCL) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716087
• Other study ID #: LP-168-CN201
• Status: Recruiting
• Phase: Phase 2
• Start date: February 21, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Guangzhou Lupeng Pharmaceutical Company LTD.
• Contact: Jun Zhu, MD, PhD
• Phone: 86-010-88196596
• Email: zj[@]bjcancer.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 31, 2025
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma (MCL)

Intervention

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.

Locations

Country	Name	City	State
China	Affiliated hospital of hebei university	Baoding
China	Beijing Boren Hospital	Beijing
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Friendship hospital	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Changchun
China	Hunan cancer hospital	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu
China	West China School of Medicine	Chengdu	Sichuan
China	The first affiliated hospital of Chongqing mediacal university	Chongqing	Chongqing
China	The second hospital of dalian medical university	Dalian	Liaoning
China	The First People's Hospital of Foshan	Foshan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Fujian Medical university union hospital	Fuzhou	Fujian
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	Sun Yat-sen Memorial Hospital	Guangzhou
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Harbin First Hospital	Ha'erbin	Heilongjiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Anhui provincial cancer hospital	Hefei	Anhui
China	The first affiliated hospital of Anhui medical university	Hefei	Anhui
China	Qilu hospital of Shandong university	Jinan	Shandong
China	Shandong Cancer Hospital	Jinan	Shandong
China	Gansu provincial cancer hospital	Lanzhou	Gansu
China	Meizhou people'shospital	Meizhou	Guangdong
China	The first affiliated hospital of Nanchang university	Nanchang	Jiangxi
China	Jiangsu cancer hospital	Nanjing	Jiangsu
China	Jiangsu province hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Shengjing hospital of China medical university	Shenyang	Liaoning
China	The first hospital of China medical university	Shenyang	Liaoning
China	The fourth hospital of Hebei medical university	Shijia Zhuang	Hebei
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Tianjin Hematonosis Hospital	Tianjin	Tianjin
China	Tianjin medical university cancer hospital	Tianjin	Tianjin
China	The first affiliated hospital of Wenzhou medical university	Wenzhou
China	Hubei Cancer Hospital	Wuhan
China	Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhan
China	The first affiliated hospital of Xiamen university	Xiamen	Fujian
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan provincial people's hospital	Zhengzhou	Henan
China	The first affiliated hospital of Zhengzhou university	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Lupeng Pharmaceutical Company LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 24 Months
Secondary	Overall Response Rate	To assess the anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by investigator.	Up to 24 Months
Secondary	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.	Up to 24 Months
Secondary	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.	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.
Secondary	Overall survival	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.
Secondary	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.	Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.
Secondary	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.	Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.
Secondary	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	From first dose of study drug to 28 days after last dose of study drug
Secondary	Maximum Observed Plasma Concentration (Cmax)	Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of LP-168	Up to 24 hours post dose
Secondary	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	Up to 24 hours post dose
Secondary	Maximum Observed Plasma Concentration (Tmax)	PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of LP-168	Up to 24 hours post dose
Secondary	Half-life period (T1/2)	PK As Assessed By Time To Half-life period (T1/2) Of LP-168	Up to 24 hours post dose
Secondary	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.)	Up to 24 Months