A Study of CA-4948 in Patients With Relapsed or Refractory Hematologic Malignancies

  • STATUS
    Not Recruiting
  • End date
    May 5, 2025
  • participants needed
    181
  • sponsor
    Curis, Inc.
Updated on 18 April 2022

Summary

This is a multi-center, open-label trial to evaluate oral administration of emavusertib (CA-4948) in adult patients with relapsed/refractory hematologic malignancies. Part A will evaluate escalating doses of emavusertib either as monotherapy (Part A1) or in combination with ibrutinib for non- Hodgkin's Lymphoma (NHL), Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (Part A2). Once the combination dose has been determined, Part B will comprise an expansion phase to assess efficacy (CR rate or ORR) and safety of the RP2D of emavusertib and ibrutinib in 4 Non-Hodgkin Lymphoma (NHL) disease-specific cohorts:

  • Cohort 1 - Marginal zone lymphoma (MZL)
  • Cohort 2 - activated B-cell (ABC) diffuse large B-cell lymphoma (DLBCL) or extranodal subtypes: Leg-, testicular-, or not otherwise specified (NOS)-type
  • Cohort 3 - Primary central nervous system lymphoma (PCNSL)
  • Cohort 4 - Patients receiving ibrutinib monotherapy who have developed adaptive, secondary resistance. Indications include:
  • Mantle Cell Lymphoma (MCL), MZL, CLL/SLL, or WM/LPL
  • Indications for which ibrutinib is National Comprehensive Cancer Network (NCCN)-listed (e.g., PCNSL)
  • Patients with NHL and known myddosome mutations
  • Patients may be candidates for maintaining ibrutinib while emavusertib will be added for resistance reversal. A brief gap of ibrutinib therapy of <3 weeks is acceptable.

Details
Condition Relapsed Hematologic Malignancy, Refractory Hematologic Malignancy
Treatment Ibrutinib, CA-4948, Emavusertib
Clinical Study IdentifierNCT03328078
SponsorCuris, Inc.
Last Modified on18 April 2022

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