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A Phase 1, Dose Escalation, Safety and Tolerability Study of NX-2127, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies

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Trial Profile

A Phase 1, Dose Escalation, Safety and Tolerability Study of NX-2127, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 19 Jul 2024

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At a glance

  • Drugs NX-2127 (Primary)
  • Indications B-cell leukaemia; B-cell lymphoma; Chronic lymphocytic leukaemia; CNS cancer; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Waldenstrom's macroglobulinaemia
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Sponsors Nurix

    • Most Recent Events

    • 11 Jul 2024 According to a Nurix media release, Nurix plans to reinitiate enrollment with the new chirally controlled drug product in a standard dose escalation study within the current Phase 1a/1b trial in the second half of 2024
    • 12 Mar 2024 According to a Nurix media release, the company reinitiates enrollment
    • 12 Mar 2024 According to a Nurix media release, the company announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the U.S. Phase 1a/1b study evaluating NX-2127 in adults with relapsed/refractory B-cell malignancies. The partial clinical hold on the study was announced by Nurix on November 1, 2023, following the companys communication to the FDA of its intention to transition to an improved manufacturing process.
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