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

NCT04993690 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LP-168-CN101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open-label, multi-center Phase 1/2 study of oral LP-168 in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

Conditions

B-cell Lymphoma

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose (MTD)

  Phase 1a

  Up to 24 Months

• Recommended dose for Phase2 (RP2D)

  Phase Ia/Ib

  Up to 24 Months

• To evaluate the safety of LP-168 by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0

  Phase Ia/Ib

  Up to 24 Months

Secondary Outcomes (7)

• Overall Response Rate

  Up to 24 Months

• Progression Free Survival

  Up to 24 Months

• Duration of Response

  Up to 24 Months

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

  Up to 48 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 48 hours post dose

Study Arms (6)

Phase I Dose Escalation

EXPERIMENTAL

Dose Escalation and determination of MTD; multiple dose levels of LP-168 to be evaluated

Drug: LP-168 tablet

Phase I Dose Expansion A

EXPERIMENTAL

CLL/SLL patients treated with prior regimens.

Drug: LP-168 tablet

Phase I Dose Expansion B

EXPERIMENTAL

CLL/SLL patients with no prior therapy.

Drug: LP-168 tablet

Phase I Dose Expansion C

EXPERIMENTAL

MCL patients treated with prior regimens.

Drug: LP-168 tablet

Phase I Dose Expansion D

EXPERIMENTAL

WM patients treated with prior regimens.

Drug: LP-168 tablet

Phase I Dose Expansion E

EXPERIMENTAL

MZL patients treated with prior regimens.

Drug: LP-168 tablet

Interventions

LP-168 tablet DRUG

Subjects to take LP-168 orally with 240mL water, without food, Once daily or twice daily

Phase I Dose Escalation; Phase I Dose Expansion A; Phase I Dose Expansion B; Phase I Dose Expansion C; Phase I Dose Expansion D; Phase I Dose Expansion E

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Per 2017 revised WHO lymphoma classification criteria, subject must have either:
• Diagnosed with relapsed or refractory DLBCL or FL and require treatment in the opinion of the Investigator and have received 2 lines SOC.
• Diagnosed with relapsed or refractory non-Hodgkin's lymphoma associated with B-cell proliferation (such as CLL\\ SLL \\ MCL \\ MZL \\ WM, etc.) in need of treatment in the opinion of the Investigator and have received 1 line SOC.
• Adequate hematologic function.
• Adequate hepatic and renal function.
• Ability to receive study drug therapy orally and willing to receive examinations.
• 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.

You may not qualify if:

• According to the 2017 revised WHO Lymphoma Classification Criteria, patients diagnosed with the following diseases: Burkitt lymphoma or Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, and post-transplant lymphoproliferative disease(PTLD).
• Prior malignancy (other than the disease under study) within the past 3 years, except for curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix or breast cancer.
• 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 with obvious symptoms; Autoimmune hemolytic anemia or Idiopathic thrombocytopenic purpura. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
• Subjects who cannot tolerate urine collection, venipuncture, lymph node biopsy, and bone marrow aspiration.

Sponsors & Collaborators

• Guangzhou Lupeng Pharmaceutical Company LTD.: lead

Study Sites (3)

Peking University Third Hospital

Beijing, Beijing Municipality, 100089, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jun Zhu

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Central Study Contacts

Jun Zhu, MD, PhD

CONTACT

+86-010-88196596; zj@bjcancer.org

Yuqin Song, MD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose Escalation and determination of MTD; multiple dose levels of LP-168 to be evaluated

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 6, 2021
• Study Start: July 6, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 23, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)