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

PHASE1RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 19, 2021

Primary Completion Date

July 31, 2025

Study Completion Date

December 31, 2025

Conditions
CLL/SLLWaldenstrom MacroglobulinemiaFollicular LymphomaDiffuse Large B Cell LymphomaMantle Cell LymphomaMarginal Zone LymphomaHairy Cell Leukemia
Interventions
DRUG

LP-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.

DRUG

LP-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.

Trial Locations (4)

27708

RECRUITING

Duke Univerisity, Durham

43210

RECRUITING

Ohio State University, Columbus

45221

RECRUITING

University of Cincinnati, Cincinnati

84112

RECRUITING

Huntsman Cancer Institute, University of Utah, Salt Lake City

Sponsors
All Listed Sponsors
lead

Newave Pharmaceutical Inc

INDUSTRY