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

This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult patients with Relapsed or Refractory Hematologic Malignancies. The trial will be conducted in 2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or Refractory Hematologic Malignancies, and a Dose Expansion Phase (Part B) of CA-4948 in patients with selected RR hematologic malignancies (including NHL with and without myeloid differentiation primary response 88 (MYD88) mutations, and AML).
December 20, 2018
Cancer (Heme) - Other Malignant Oncology, Cancer, Hematologic, Cancer (Hematology) - All Hematologic Diseases
Krish Patel, MD
Curis, Inc.

Swedish Cancer Institute

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 hematologic malignancies. For NHL: Confirmed B-cell NHL (as per the World Health Organization [WHO] 2016 classification including WM/LPL). For AML: Diagnosis of histopathologically confirmed AML (as per the World Health Organization [WHO] 2016 classification; Owen 2013) that is relapsed and/or refractory.
  5. Relapsed or refractory disease 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 for NHL
  4. Any prior anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 14 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 or 5 half-lives, whichever is shorter, 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
  9. Diagnosis of acute promyelocytic leukemia (APL, M3) for AML
  10. Hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of CA-4948 for AML
  11. Blast transformation of CML into AML

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