A Phase 1 study of LP-108 in patients with blood cancers

• Research type

  Research Study

• Full title

  A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).

• IRAS ID

  300272

• Contact name

  Ann Vollmer

• Contact email

  avollmer@newavepharma.com

• Sponsor organisation

  Newave Pharmaceutical Inc.

• Eudract number

  2021-001402-29

• Clinicaltrials.gov Identifier

  NCT04139434

• Duration of Study in the UK

  0 years, 10 months, 1 days

• Research summary

  The aim of this first-in-human (FIH) study of study drug LP-108 for patients with certain blood cancers who have relapsed (worsened after previous improvement) or become refractory (resistant) to treatment is to identify the recommended safe dose by understanding the dose-limiting toxicity (DLT, side effect of the drug serious enough to prevent an increase in dose or level of that treatment) and maximum tolerated dose (MTD, the highest dose of study drug that does not produce unacceptable side effects) in humans. The dose levels for the Phase 1 clinical study are selected based on an evaluation of the toxicology(study of poisons, including the source, effect, and treatment of poisoning) data and in vivo efficacy data in relevant oncology models
  The study will be conducted in approximately 76 patients from USA, Europe and UK. The first part of the study is used to increase the dose of LP-108, which is given orally once per day, in groups of 3 people. the first dose is given to 3 patients who are observed for 28 days (1 Cycle) and if there are no previously identified side effects then the dose is increased for next 3 patients. If there are side effects which are called dose limiting toxicities (DLTs) at any time, the group of 3 is extended to 6 to ensure its safe before increasing the dose in the next 3 patients, this continues until a maximum tolerated dose is established. Patients can continue treatment with LP-108 until disease progression (worsening of disease) or development of unacceptable toxicity (side effect), or a clinical observation satisfying another withdrawal from treatment criterion is noted.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  21/LO/0611

• Date of REC Opinion

  11 Oct 2021

• REC opinion

  Further Information Favourable Opinion