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

• Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05716087
• Collaborator: (none)
• Enrollment: 62
• Locations: 30
• Arm: 1
• Anticipated Duration (Months): 34.1
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mantle Cell Lymphoma (MCL)	Drug: LP-168	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 62 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Feb 28, 2023
• Anticipated Primary Completion Date: Feb 28, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate [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).

Secondary Outcome Measures

1. Overall Response Rate [Up to 24 Months]

   To assess the anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by investigator.

2. Complete remission rate [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.

3. Progression Free Survival [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.

4. Overall survival [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.

5. Duration of Response (DOR) [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.

6. Time to Response (TTR) [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.

7. Safety Assessment [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

8. Maximum Observed Plasma Concentration (Cmax) [Up to 24 hours post dose]

   Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of LP-168

9. Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) [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

10. Maximum Observed Plasma Concentration (Tmax) [Up to 24 hours post dose]

    PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of LP-168

11. Half-life period (T1/2) [Up to 24 hours post dose]

    PK As Assessed By Time To Half-life period (T1/2) Of LP-168

12. Quality of life (QoL) [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.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui provincial cancer hospital	Hefei	Anhui	China
2	The first affiliated hospital of Anhui medical university	Hefei	Anhui	China
3	Peking University Third Hospital	Beijing	Beijing	China	100089
4	Beijing Cancer Hospital	Beijing	Beijing	China	100142
5	The first affiliated hospital of Chongqing mediacal university	Chongqing	Chongqing	China
6	Fujian Cancer Hospital	Fuzhou	Fujian	China
7	Fujian Medical university union hospital	Fuzhou	Fujian	China
8	The first affiliated hospital of Xiamen university	Xiamen	Fujian	China
9	Gansu provincial cancer hospital	Lanzhou	Gansu	China
10	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060
11	Meizhou people'shospital	Meizhou	Guangdong	China
12	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China
13	The fourth hospital of Hebei medical university	Shijia Zhuang	Hebei	China
14	Harbin First Hospital	Ha'erbin	Heilongjiang	China
15	Henan Cancer Hospital	Zhengzhou	Henan	China
16	Henan provincial people's hospital	Zhengzhou	Henan	China
17	The first affiliated hospital of Zhengzhou university	Zhengzhou	Henan	China
18	Hunan cancer hospital	Changsha	Hunan	China
19	Jiangsu cancer hospital	Nanjing	Jiangsu	China
20	Jiangsu province hospital	Nanjing	Jiangsu	China
21	The first affiliated hospital of Nanchang university	Nanchang	Jiangxi	China
22	The second hospital of dalian medical university	Dalian	Liaoning	China
23	Shengjing hospital of China medical university	Shenyang	Liaoning	China
24	The first hospital of China medical university	Shenyang	Liaoning	China
25	Qilu hospital of Shandong university	Jinan	Shandong	China
26	Shandong Cancer Hospital	Jinan	Shandong	China
27	West China School of Medicine	Chengdu	Sichuan	China
28	Tianjin Hematonosis Hospital	Tianjin	Tianjin	China
29	Tianjin medical university cancer hospital	Tianjin	Tianjin	China
30	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China

Sponsors and Collaborators

• Guangzhou Lupeng Pharmaceutical Company LTD.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guangzhou Lupeng Pharmaceutical Company LTD.
• ClinicalTrials.gov Identifier: NCT05716087
• Other Study ID Numbers: LP-168-CN201
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 9, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Mantle-Cell

Study Results

No Results Posted as of Feb 9, 2023