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Phase I

An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

  • Study HIC#:2000022049
  • Last Updated:05/09/2024

This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult patients with Relapsed or Refractory NHL. The trial will be conducted in 2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma, (RR NHL) and a Dose Expansion Phase (Part B) of CA-4948 in patients with RR NHL with and without myeloid differentiation primary response 88 (MYD88) mutations. During Part B, patients will be enrolled regardless of MYD88 mutation status.

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    Trial Purpose and Description

    Primary Outcome Measures :

    1. The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle [ Time Frame: 12 months ]Toxicity will be graded and recorded according to the NCI CTCAE v4.03.
    2. Maximum tolerated dose (MTD) of CA-4948 measured by dose-limiting toxicities (DLTs) [ Time Frame: 12 months ]MTD determined by the highest dose level studied at which fewer than 2 out of 6 subjects (<33%) experience a dose limiting toxicity
    3. Recommended Phase 2 Dose (RP2D) of CA-4948 based on overall tolerability data [ Time Frame: 12 months ]RP2D selected based on overall tolerability data from all patients treated at different dose levels and will not exceed the MTD.

    Eligibility Criteria

    Inclusion Criteria:

    1. Males and females greater than or equal to 18 years of age
    2. Life expectancy of at least 3 months
    3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
    4. Diagnosis of histopathologically confirmed B-cell NHL (as per the World Health Organization [WHO] 2016 classification) including WM/LPL.
    5. Relapsed or refractory disease (as defined below) for which patients are ineligible for or have exhausted standard therapeutic options that would be considered standard of care

    Exclusion Criteria:

    1. Active central nervous system (CNS) involvement of their malignancy.
    2. Radiotherapy delivered to non-target lesions within one week prior to starting study treatment or delivered to target lesions that will be followed on the study (NOTE: prior sites of radiation will be recorded)
    3. History of allogeneic stem cell transplant
    4. Any prior anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 21 days prior to start of CA-4948
    5. Current or planned glucocorticoid therapy, with the following exceptions:
      1. Doses ≤ 10 mg/day prednisolone or equivalent is allowed, provided that the steroid dose has been stable or tapering for at least 14 days prior to the first dose of CA-4948
      2. Inhaled, intranasal, intraarticular and topical steroids are permitted
    6. Use of any investigational agent within 28 days prior to start of CA-4948
    7. Presence of an acute or chronic toxicity resulting from prior anti-cancer therapy, with the exception of alopecia, that has not resolved to Grade ≤ 1 within 7 days prior to start of CA-4948 unless approved by the Medical Monitor
    8. Known allergy or hypersensitivity to any component of the formulation of CA-4948 used in this study

    Principal Investigator

    Sub-Investigators

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