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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Newave Pharmaceutical Inc
Study ID
NCT04775745
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LP-168 — DRUG
    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.
  • LP-168 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 19, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Phase
    Three to six subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-168 on a once or twice daily schedule for 28 days, starting at a dose of 100 mg/day.
  • Experimental: Dose Expansion Phase
    Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Up to 24 months, each cycle is 28 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Duke UniverisityDurhamNorth Carolina27708-
University of CincinnatiCincinnatiOhio45221-
Ohio State UniversityColumbusOhio43210-
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112-

Find similar trials in Durham, NC

By research site
Duke Univerisity· Durham, NCUniversity of Cincinnati· Cincinnati, OHOhio State University· Columbus, OHHuntsman Cancer Institute, University of Utah· Salt Lake City, UT

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