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

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

sites

Churchill Hospital, Oxford University

Oxford, OX3 7LE

Principal Investigator: Paresh Vyas

from

Oxford,