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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/23/2019
Start Date:September 12, 2017
End Date:August 2022
Contact:Mark Chao, MD PhD
Email:medical@fortyseveninc.com
Phone:1-650-352-4150

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A Phase 1b Trial of Hu5F9-G4 Monotherapy or Hu5F9-G4 in Combination With Azacitidine in Patients With Hematological Malignancies

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.


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
We found this trial at
7
sites
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: David Sallman
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Aurora, Colorado 80045
Principal Investigator: Daniel Pollyea
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Aurora, CO
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Duarte, California 91010
Principal Investigator: Guido Marcucci
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Duarte, CA
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903 East 104th Street
Kansas City, Missouri 64131
Principal Investigator: Suman Kambhampati
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Kansas City, MO
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2300 Patterson Street
Nashville, Tennessee 37203
Principal Investigator: William Donnellan
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Nashville, TN
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Mark Frattini
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oxford, OX3 7LE
Principal Investigator: Paresh Vyas
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Oxford,
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