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

Last updated: October 7, 2024
Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.
Overall Status: Active - Recruiting

Phase

1

Condition

Hematologic Cancer

Lymphoproliferative Disorders

Lymphoma

Treatment

LP-168 tablet

Clinical Study ID

NCT04993690
LP-168-CN101
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • 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 followingmenarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] orsurgically sterile) to observe conventional and effective birth control.

Exclusion

Key Exclusion Criteria:

  • According to the 2017 revised WHO Lymphoma Classification Criteria, patientsdiagnosed with the following diseases: Burkitt lymphoma or Burkitt-like lymphoma,lymphoblastic lymphoma/leukemia, and post-transplant lymphoproliferativedisease(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 situof the cervix or breast cancer.

  • Subjects who have received the following treatments within 4 weeks or 5 half-livesbefore 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 firstdose 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, includingHIV, HBV, HCV, syphilis positive or active bacterial and fungal infections; Diseaseaffects the central nervous system with obvious symptoms; Autoimmune hemolyticanemia or Idiopathic thrombocytopenic purpura. Any gastrointestinal conditions thatmay severely affect the study drug absorption or pharmacokinetic parameters.

  • Subjects who cannot tolerate urine collection, venipuncture, lymph node biopsy, andbone marrow aspiration.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: LP-168 tablet
Phase: 1
Study Start date:
July 06, 2021
Estimated Completion Date:
June 30, 2025

Study Description

This study includes 2 parts: phase 1a (LP-168 monotherapy dose escalation) and phase 1b (LP-168 dose expansion). In phase 1a, patients will be enrolled using an 3+3 design. The starting dose of LP-168 in oral tablet form is 100 mg/day (e.g., 100 mg once daily [QD]). Once the MTD and/or RP2D is identified in phase 1a dose escalation, enrollment will continue to phase 1b dose expansion. Cycle length will be 28 days.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100089
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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