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.
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
| Drug | Synonyms | Arms |
|---|
| Hu5F9-G4 | | Relapsed/Refractory AML or MDS |
| Azacitidine | VIDAZA | Treatment-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
| Name | Type | Description | Interventions |
|---|
| Relapsed/Refractory AML or MDS | Experimental | Patients with relapsed or refractory AML or intermediate/high risk MDS will receive Hu5F9-G4 monotherapy | |
| Treatment-naive Unfit AML or MDS | Experimental | 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 | |
| Rollover | Experimental | Patients on a previous AML Phase 1 trial (SCI-CD47-002) with clinical benefit on Hu5F9-G4 treatment will receive Hu5F9-G4 monotherapy | |
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
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