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

This study is not yet open for participant recruitment.
Verified August 2017 by Forty Seven, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03248479
First Posted: August 14, 2017
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Forty Seven, Inc.
  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.


Condition Intervention Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes Drug: Hu5F9-G4 Drug: Azacitidine Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4 in Combination With Azacitidine in Patients With Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by Forty Seven, Inc.:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 28 days ]
    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

  • Objective Response Rate [ Time Frame: 8 weeks ]
    Objective Response Rate as defined by the Investigator according to protocol-specified criteria based on European LeukemiaNet (ELN) AML recommendations (Döhner 2017), International Working Group (IWG) AML response criteria (Cheson 2003), or IWG MDS response criteria (Cheson 2006) where appropriate


Estimated Enrollment: 96
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Relapsed/Refractory AML or MDS
Patients with relapsed or refractory AML or intermediate/high risk MDS will receive Hu5F9-G4 monotherapy
Drug: Hu5F9-G4
Hu5F9-G4 will be administered up to twice weekly.
Experimental: Treatment-naive Unfit AML or MDS
Patients 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
Drug: Hu5F9-G4
Hu5F9-G4 will be administered up to twice weekly.
Drug: Azacitidine
Azacitidine will be administered daily for 7 days in each 28-day cycle.
Other Name: VIDAZA
Experimental: Rollover
Patients on a previous AML Phase 1 trial (SCI-CD47-002) with clinical benefit on Hu5F9-G4 treatment will receive Hu5F9-G4 monotherapy
Drug: Hu5F9-G4
Hu5F9-G4 will be administered up to twice weekly.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248479


Contacts
Contact: Mark Chao, MD PhD 1-650-352-4150 medical@fortyseveninc.com
Contact: Chris Takimoto, MD PhD 1-650-352-4150 medical@fortyseveninc.com

Locations
United States, Tennessee
Sarah Cannon Research Institute (Tennessee Oncology) Not yet recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: William Donnellan         
Sponsors and Collaborators
Forty Seven, Inc.
Investigators
Study Chair: Mark Chao, MD PhD Forty Seven, Inc.
  More Information

Responsible Party: Forty Seven, Inc.
ClinicalTrials.gov Identifier: NCT03248479     History of Changes
Other Study ID Numbers: 5F9005
First Submitted: August 10, 2017
First Posted: August 14, 2017
Last Update Posted: August 21, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Forty Seven, Inc.:
Hu5F9-G4
CD47
azacitidine

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors