RecruitingPhase 1NCT04993690

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

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


Sponsor

Guangzhou Lupeng Pharmaceutical Company LTD.

Enrollment

200 participants

Start Date

Jul 6, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called LP-168 in patients with various types of B-cell blood cancers (including diffuse large B-cell lymphoma, follicular lymphoma, chronic lymphocytic leukemia, mantle cell lymphoma, and others) that have relapsed or are no longer responding to previous treatments. **You may be eligible if...** - You are 18 or older with a confirmed B-cell lymphoma or leukemia diagnosis - For DLBCL or follicular lymphoma: your cancer has relapsed or stopped responding after at least 2 prior treatments - For other B-cell cancers (CLL, SLL, MCL, MZL, WM): after at least 1 prior treatment - You have adequate blood, liver, and kidney function - You are able to take oral medication and willing to attend required exams **You may NOT be eligible if...** - You have Burkitt lymphoma, lymphoblastic leukemia, or post-transplant lymphoma - You had another cancer in the past 3 years (except certain treated skin or cervical cancers) - You have active HIV, hepatitis B, hepatitis C, or active infections - You are pregnant or breastfeeding - You have significant heart problems or prolonged QT interval on ECG - You cannot swallow the study drug or have severe gastrointestinal problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLP-168 tablet

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


Locations(3)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT04993690


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