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.

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Newave Pharmaceutical Inc
Study ID
NCT04771572
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Lymphocytic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Chronic Myelomonocytic Leukemia-2
  • Multiple Myeloma
  • Myelodysplastic Neoplasm in Blast Phase
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Myelofibrosis
  • Myeodysplastic Syndrome
  • Non Hodgkin Lymphoma
  • Richter Transformation
  • Small Lymphocytic Lymphoma
  • T-cell-prolymphocytic Leukemia

Eligibility Criteria

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

Interventions

  • LP-118 — DRUG
    novel, oral, selective treatment for hematological malignancies tested through ascending dose levels

Study Details

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.

Key Dates

Start date
May 8, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Dose Escalation Phase
    Phase 1a dose-escalation will begin with group 1 and proceed until DLT is observed and MTD is established, or until an RP2D is established. Subjects enrolled in the dose cohorts will follow the 3+3 study design, starting with an accelerated step-up dosing schedule (with a starting dose of 20 mg, 50 mg, 100 mg once daily) until they reach the designated target dose (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg). Once the MTD or RP2D is established for group 1, the phase 1a dose escalation can proceed for group 2. The starting dose level for group 2 will be one dose level below the MTD or RP2D established for group 1.
  • Experimental: Dose Expansion Phase
    Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups. One or more RP2D may be explored. Definition of these cohorts will be accomplished by protocol amendment, and in light of emerging data from Phase 1a.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: At the end of cycle 1 (each cycle is 28 days) ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of North CarolinaChapel HillNorth Carolina27514-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
University of CincinnatiCincinnatiOhio45229-
The Ohio State UniversityColumbusOhio43210-
MD Anderson Cancer CenterHoustonTexas77030-
University of UtahSalt Lake CityUtah84112-

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