Actively Recruiting
A Phase 1 Open-Label Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of LP-168 in Adult Patients With Relapse or Refractory B-Cell Lymphoma
Led by Guangzhou Lupeng Pharmaceutical Company LTD. · Updated on 2025-09-23
200
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating LP-168, an oral drug, in adults with relapse or refractory B-cell lymphoma, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and non-Hodgkin's lymphoma (NHL). This open-label, multi-center Phase 1 study aims to find the maximum tolerated dose and recommended dose for further study while assessing safety, tolerability, and early antitumor activity. The study has two parts: Phase 1a involves dose escalation of LP-168 tablets starting at 100 mg once daily, using a 3+3 design to identify the best dose. Phase 1b expands enrollment to more patients at the recommended dose. Treatment cycles last 28 days, and participants take LP-168 orally once or twice daily with water, without food. Participants will be monitored for up to 24 months for safety, response to treatment, and drug levels in the blood. Assessments include tracking adverse events, tumor response, progression-free survival, and pharmacokinetics such as drug concentration over time. The study involves blood tests, biopsies, and other exams to understand how LP-168 works and its effects on lymphoma.
CONDITIONS
Brief Title
A Study of LP-168 in Participants With Relapse or Refractory B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) needing treatment and have received 2 lines of standard care.
- Diagnosed with relapsed or refractory non-Hodgkin's lymphoma associated with B-cell proliferation (such as CLL/SLL, MCL, MZL, WM) needing treatment and have received 1 line of standard care.
- Adequate blood cell counts and function.
- Adequate liver and kidney function.
- Able to take oral study drug and willing to undergo study examinations.
- Men and women of reproductive potential agree to use effective birth control.
You will not qualify if you...
- Diagnosed with Burkitt lymphoma or Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, or post-transplant lymphoproliferative disease.
- Any other cancer within the past 3 years except treated basal or squamous skin cancer, cervix carcinoma in situ, or breast cancer.
- Received antitumor therapies, investigational treatments, major surgery, severe trauma, or radiotherapy within 4 weeks or 5 half-lives before first dose.
- Received steroids, herbal medicines for cancer, strong/moderate CYP3A inhibitors or inducers, or drugs causing QTc prolongation within 2 weeks before first dose.
- Active infections (HIV, HBV, HCV, syphilis, bacterial, fungal), CNS disease with symptoms, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, or severe gastrointestinal conditions affecting drug absorption.
- Unable to tolerate urine collection, blood draws, lymph node biopsy, or bone marrow aspiration.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles up to 24 months or until disease progression or discontinuation
Participants receive LP-168 oral tablets once or twice daily in repeated 28-day cycles during dose escalation and dose expansion phases.
Visits occur regularly during each 28-day cycle for dosing and assessments
Trial Site Locations
Total: 3 locations
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100089
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
J
Jun Zhu, MD, PhD
Y
Yuqin Song, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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