RecruitingPhase 1NCT04775745

Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.

A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.

Sponsor

Newave Pharmaceutical Inc

Enrollment

60 participants

Start Date

Jul 19, 2021

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma CLL/SLL Hairy Cell Leukemia Waldenstrom Macroglobulinemia

Summary

This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an oral drug called LP-168 for people with B-cell blood cancers (including certain lymphomas and leukemias) that have come back or stopped responding to prior treatments. LP-168 targets a protein called BTK that drives the growth of these cancers. **You may be eligible if...** - You have a B-cell blood cancer such as CLL, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, large B-cell lymphoma, hairy cell leukemia, or Waldenström's macroglobulinemia - You have received at least 2 prior treatments (for most cancer types) - Your blood clotting, kidney, and liver function meet the study requirements - You are 18 or older **You may NOT be eligible if...** - You have not tried at least two prior treatments - Your kidneys are not functioning well enough (creatinine clearance below 60 mL/min) - You are pregnant or breastfeeding - You have had recent major bleeding or surgery 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

For the dose escalation phase, LP-168 will be given once or twice daily at the following dose levels:100 mg QD,150 mg QD, 100 mg BID, 300 mg QD, 150 mg BID, 450 mg QD, 225 mg BID, 600 mg QD, 800 mg QD, and 1000 mg QD.

DRUGLP-168

For the dose expansion phase, subjects will receive once or twice daily dose of LP-168 at the Recommended Phase 2 Dose (RP2D). The RP2D may be as high as the MTD and will be determined following evaluation of Phase I Dose Escalation results.