Clinical Trials /

Hu5F9-G4 Monotherapy or Hu5F9-G4 in Combination With Azacitidine in Patients With Hematological Malignancies

NCT03248479

Description:

This trial will evaluate Hu5F9-G4, a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. In this study, Hu5F9-G4 may be given alone or in combination with azacitidine to patients with acute myeloid leukemia (AML) or higher risk myelodysplastic syndrome (MDS). Azacitidine is a drug used for treatment of AML or MDS in patients who are not eligible for typical chemotherapy. The major aims of the study are: to confirm the safety and tolerability of Hu5F9-G4 monotherapy in a relapsed/refractory AML and MDS population, and of Hu5F9-G4 in combination with azacitidine in previously untreated AML and MDS; and to evaluate the efficacy of Hu5F9-G4 monotherapy in relapsed/refractory AML/MDS, and of Hu5F9-G4 in combination with azacitidine in previously untreated AML/MDS, as measured by the objective response rate.

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Hu5F9-G4 Monotherapy or Hu5F9-G4 in Combination With Azacitidine in Patients With Hematological Malignancies
  • Official Title: A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4 in Combination With Azacitidine in Patients With Hematological Malignancies

Clinical Trial IDs

  • ORG STUDY ID: 5F9005
  • NCT ID: NCT03248479

Conditions

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes

Interventions

DrugSynonymsArms
Hu5F9-G4Relapsed/Refractory AML or MDS
AzacitidineVIDAZATreatment-naive Unfit AML or MDS

Purpose

This trial will evaluate Hu5F9-G4, a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. In this study, Hu5F9-G4 may be given alone or in combination with azacitidine to patients with acute myeloid leukemia (AML) or higher risk myelodysplastic syndrome (MDS). Azacitidine is a drug used for treatment of AML or MDS in patients who are not eligible for typical chemotherapy. The major aims of the study are: to confirm the safety and tolerability of Hu5F9-G4 monotherapy in a relapsed/refractory AML and MDS population, and of Hu5F9-G4 in combination with azacitidine in previously untreated AML and MDS; and to evaluate the efficacy of Hu5F9-G4 monotherapy in relapsed/refractory AML/MDS, and of Hu5F9-G4 in combination with azacitidine in previously untreated AML/MDS, as measured by the objective response rate.

Trial Arms

NameTypeDescriptionInterventions
Relapsed/Refractory AML or MDSExperimentalPatients with relapsed or refractory AML or intermediate/high risk MDS will receive Hu5F9-G4 monotherapy
  • Hu5F9-G4
Treatment-naive Unfit AML or MDSExperimentalPatients with previously untreated AML who are ineligible for standard induction chemotherapy, or previously untreated intermediate/high risk MDS, will receive Hu5F9-G4 in combination with azacitidine
  • Hu5F9-G4
  • Azacitidine
RolloverExperimentalPatients on a previous AML Phase 1 trial (SCI-CD47-002) with clinical benefit on Hu5F9-G4 treatment will receive Hu5F9-G4 monotherapy
  • Hu5F9-G4

Eligibility Criteria

        Inclusion Criteria:

          -  Meets the criteria below for the appropriate cohort:

               1. Relapsed/Refractory Cohorts: Pathologically confirmed relapsed or refractory
                  (primary refractory and/or relapsed refractory) AML or confirmed intermediate,
                  high, or very high risk MDS that is relapsed, refractory or intolerant to
                  conventional therapy

               2. Treatment-naïve/ Unfit Cohorts: Previously untreated patients with histological
                  confirmation of AML who are ineligible for treatment with a standard cytarabine
                  and anthracycline induction regimen; or previously untreated patients with
                  intermediate, high, or very high risk MDS. Prior and concurrent therapy with
                  hydroxyurea, oral etoposide, erythroid and/or myeloid growth factors is allowed.

               3. Rollover Cohort: Patients on active Hu5F9-G4 therapy on the Phase 1 AML
                  (SCI-CD47-002) trial who are deriving clinical benefit by Investigator assessment

          -  White blood cell (WBC) count ≤ 20 x 10E3/µL

          -  Adequate performance status and hematological, liver, and kidney function

        Exclusion Criteria:

          -  Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents
             (with exception of Hu5F9-G4 for patients in the Rollover cohort).

          -  Treatment-naïve/Unfit Cohorts Only: Any prior anti-leukemic therapy (excluding
             hydroxyurea or oral etoposide), prior treatment with hypomethylating agents and/or low
             dose cytarabine.

          -  Acute promyelocytic leukemia.

          -  Known inherited or acquired bleeding disorders.

          -  Previous allogeneic hematopoietic stem cell transplant within 6 months prior to
             enrollment, active graft versus host disease (GVHD), or requiring transplant-related
             immunosuppression.

          -  Clinical suspicion of active central nervous system (CNS) involvement by leukemia

          -  Known active or chronic hepatitis B or C infection or HIV

          -  Pregnancy or active breastfeeding
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse Events
Time Frame:28 days
Safety Issue:
Description:Adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 or customized AE severity grading as defined in the protocol

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Forty Seven, Inc.

Trial Keywords

  • Hu5F9-G4
  • CD47
  • azacitidine

Last Updated