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A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.

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Trial Profile

A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 18 Feb 2026

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At a glance

  • Drugs Rocbrutinib (Primary)
  • Indications B-cell leukaemia; B-cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Hairy cell leukaemia; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Waldenstrom's macroglobulinaemia
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Newave Pharmaceuticals

Most Recent Events

  • 13 Feb 2026 Planned End Date changed from 31 Dec 2025 to 31 Dec 2027.
  • 13 Feb 2026 Planned primary completion date changed from 31 Jul 2025 to 31 Dec 2027.
  • 12 Dec 2023 Initial Results (n= 43 at data cut off 10 Jul 2023) assessing safety evaluation focusing on DLT evaluable pts, and efficacy evaluation focusing on the cohort of pts with CLL presented at the 65th American Society of Hematology Annual Meeting and Exposition

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