LP-168 for Relapsed or Refractory B-cell Malignancies

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

Recruiting Phase 1 Interventional Study
CLL/SLL Waldenstrom Macroglobulinemia Follicular Lymphoma Diffuse Large B Cell Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Hairy Cell Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Newave Pharmaceutical Inc · Industry
Who this trial is looking for

This trial is looking for patients with specific types of B-cell cancers who have not responded to previous treatments. Participants will take a new oral medication called LP-168 to see how safe and effective it is.

Are You a Good Fit for This Trial?
Must not be taking Strong CYP3A4 inhibitorsStrong CYP2C8 inducers/inhibitorsSteroid therapy above 20 mg/dayProton pump inhibitors
Rules you out Richter's transformationSevere liver dysfunctionSevere kidney dysfunctionSerum amylase or lipase above normal limits

You may be able to join if

  • I have a B-cell malignancy such as Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia.
  • I have had at least 2 previous treatments for my cancer.
  • I have adequate kidney and liver function.
  • I have enough healthy blood cells according to screening tests.
  • I may have low-grade B-cell lymphomas.

You may not be able to join if

  • I have had any anti-cancer therapy within 14 days before starting this trial.
  • I need immediate treatment to lower my cancer burden.
  • I have serious heart issues as shown in my ECG results.
  • I have had a recent hematopoietic stem cell transplant within 90 days.
  • I have current significant complications from a prior transplant.
  • I require anticoagulation with Warfarin.
  • I have had another active cancer in the past 3 years, except certain skin cancers.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: A subject will be eligible for study participation if he/she meets the following criteria: * Subjects are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those subjects with WM, FL, MCL, DLBCL, or HCL must h…
Contacts

Anna Chen, MD, PhD

(206) 335-3820

yu@newavepharma.com

CONTACT

Stephen Anthony, DO

s.anthony@newavepharma.com

CONTACT