CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 10 months later Aug 2026 → Jul 2027
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Record History

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  1. Primary completion pushed from Aug 2026 to Jul 2027 Show 5 more changesShow less
    • Primary endpoints: details revised at 2 of 5 entries
    • Study completion pushed from Oct 2026 to Oct 2027
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 2 of 11 entries
    • Site details revised at 6 of 45 sites
  2. Study sites: 43 to 45v24
  3. Re-verified, no change to tracked fieldsv23
  4. Enrollment target: 80 to 152v22 Show 8 more changesShow less
    • Primary endpoints: 4 to 5
    • Study sites: 42 to 43
    • Study completion date: Aug 2026 to Oct 2026
    • Interventions: Emavusertib (Drug), ibrutinib (Drug) to Emavusertib (Drug), Ibrutinib (Drug)
    • Eligibility criteria expanded, about 124 words
    • Secondary endpoints revised (11)
    • Study title expanded, about 6 words
    • Study arms: 3 to 4
  5. Study sites: 37 to 42v21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 30 to 37v20
  2. Study sites: 25 to 30
    • Secondary endpoints: details revised at 1 of 11 entries
    v19
  3. Primary endpoints revised (4)v18
  4. Enrollment target: 221 to 80v17 Show 4 more changesShow less
    • Primary endpoints: 5 to 4
    • Study sites: 11 to 25
    • Eligibility criteria shortened, about 137 words
    • Study title expanded, about 3 words
  5. Site details revised at 5 of 11 sitesv16
  6. Study sites: 10 to 11v15
  7. Trial status: Active, Not Recruiting to Recruitingv14 Show 6 more changesShow less
    • Primary completion date: Nov 2023 to Aug 2026
    • Enrollment target: 181 to 221
    • Study completion date: May 2025 to Aug 2026
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 10 to 11
    • Site details revised at 10 of 10 sites
  8. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v13
  9. Primary endpoints revised (5)
    • Interventions: CA-4948 (Drug), ibrutinib (Drug) to Emavusertib (Drug), ibrutinib (Drug)
    • Eligibility criteria revised
    • Secondary endpoints revised (10)
    v12
  10. Enrollment target: 96 to 181v11 Show 6 more changesShow less
    • Primary completion date: Dec 2022 to Nov 2023
    • Primary endpoints revised (5)
    • Study completion date: Dec 2022 to May 2025
    • Eligibility criteria shortened, about 33 words
    • Secondary endpoints: 11 to 10
    • Site details revised at 2 of 10 sites
  11. Phase: Phase 1 to Phase 1/2v10
  12. Study sites: 9 to 10v9
  13. Primary completion date: Dec 2020 to Dec 2022v8 Show 8 more changesShow less
    • Primary endpoints: 3 to 5
    • Enrollment target: 110 to 96
    • Study sites: 10 to 9
    • Study completion date: Dec 2021 to Dec 2022
    • Interventions: CA-4948 (Drug) to CA-4948 (Drug), ibrutinib (Drug)
    • Eligibility criteria expanded, about 257 words
    • Secondary endpoints: 6 to 11
    • Study arms: 1 to 3
  14. Re-verified, no change to tracked fieldsv7
  15. Enrollment target: 80 to 110v6 Show 4 more changesShow less
    • Study sites: 9 to 10
    • Eligibility criteria expanded, about 64 words
    • Secondary endpoints revised (6)
    • Study title revised
  16. Enrollment target: 120 to 80
    • Study sites: 8 to 9
    • Eligibility criteria revised
    v5
  17. Site details revised at 1 of 8 sitesv4
  18. Study sites: 3 to 8v3
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date changed from estimate of Oct 2017 to Dec 28, 2017
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R/R) hematologic malignancies. This trial will be completed in four parts. In Part A1, emavusertib will be evaluated first in a dose escalating monotherapy setting to establish the safety and tolerability (complete). In Part A2, emavusertib will be evaluated in combination with ibrutinib at 560 milligrams (mg) once daily (QD) or 420 mg QD as indicated by disease (Part A2 complete). Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in participants with R/R primary central nervous system lymphoma (PCNSL) who have directly progressed on a bruton tyrosine kinase inhibitor (BTKi). In this part of the study, emavusertib will be dosed at 100 mg or 200 mg twice daily (BID) in combination with ibrutinib in 28-day treatment cycles. Part C will comprise 3 treatment arms in the second-line setting to assess the efficacy and safety of emavusertib monotherapy, ibrutinib monotherapy, and emavusertib in combination with ibrutinib in participants with R/R PCNSL who are naïve to BTKi treatment. In this part of the study, eligible second-line participants with R/R PCNSL who are naïve to BTKi treatment will be randomized 1:1:1 to 1 of 3 treatment arms: (1) emavusertib 200 mg BID, (2) ibrutinib 560 mg QD, or (3) emavusertib 200 mg BID in combination with ibrutinib 560 mg QD.
Trial Details
NCT Number NCT03328078
Lead Sponsor Curis, Inc.
Conditions
(from sponsor)		 Relapsed Hematologic Malignancy, Refractory Hematologic Malignancy, Relapsed Primary Central Nervous System Lymphoma, Refractory Primary Central Nervous System Lymphoma
Related terms Hematologic Neoplasms, Immune System Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoma, Lymphoma, Non-Hodgkin, Lymphoproliferative Disorders, Neoplasms, Recurrence
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov