RecruitingPhase 1NCT04771572

Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.

A Phase 1/1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of LP-118 in Subjects With Relapsed or Refractory Hematological Malignancies


Sponsor

Newave Pharmaceutical Inc

Enrollment

100 participants

Start Date

May 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing schedule in up to 100 subjects.


Eligibility

Min Age: 13 Years

Plain Language Summary

Simplified for easier understanding

This study tests an oral drug called LP-118 for people with a wide range of blood cancers that have come back or stopped responding to prior treatments. LP-118 targets a protein that helps blood cancer cells survive. The study covers many blood cancer types including CLL, AML, multiple myeloma, lymphomas, and others. **You may be eligible if...** - You are 18 or older (or 13–18 if you have ALL and weigh at least 40 kg) - You have a blood cancer that has relapsed or is no longer responding to treatment - You have received at least two prior treatments (for most cancer types) - Your blood counts and organ function meet the study requirements **You may NOT be eligible if...** - Your cancer is no longer classified as relapsed or refractory - You have had recent serious infections or major organ failure - You are pregnant or breastfeeding 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-118

novel, oral, selective treatment for hematological malignancies tested through ascending dose levels


Locations(8)

University of Chicago

Chicago, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT04771572


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