Safety and Efficacy of AMG 592 in Subjects With Steroid Refractory Chronic Graft Versus Host Disease



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 100
Updated:2/17/2019
Start Date:April 30, 2018
End Date:February 13, 2023
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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A Phase 1b/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics,Pharmacodynamics, and Efficacy of AMG 592 inAdult Subjects With Steroid Refractory Chronic Graft Versus Host Disease

Phase 1b To evaluate the safety and tolerability of multiple ascending doses of AMG 592 in
subjects with steroid refractory cGVHD.

Phase 2 To evaluate the efficacy of AMG 592 in subjects with steroid refractory cGVHD as
measured by ORR at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria.


Key Inclusion Criteria:

- Male or Female ≥ 18 years old at the time of signing the informed consent.

- Recipient of an allogeneic HSCT.

- Moderate to severe steroid-refractory cGVHD as defined by all following criteria:

- Diagnosed with cGVHD per the 2014 cGVHD NIH Consensus Criteria(Jagasia, 2015;
Appendix 8) within the past 2 years prior to screening.

- Steroid refractory cGVHD, defined as having persistent signs and symptoms of
cGVHD despite ≥ 4 weeks of prednisone (or equivalent) dosed at ≥ 0.25 mg/kg/day
(or ≥ 0.5 mg/kg every other day) within the 12 months prior to screening.

- Moderate to severe cGVHD (in accordance with 2014 cGVHD NIH Consensus Criteria
[Jagasia, 2015; Appendix 9]) at screening with involvement of at least one of the
following organs at the screening and baseline visits: skin, mouth, eyes,
gastrointestinal (GI) tract, liver, lungs, and joint and fascia.

- No more than 3 previous treatments for cGVHD, excluding topical agents.

- Stable dose of ≤ 1 mg/kg/day of systemic prednisone or equivalent for at least 2 weeks
prior to first dose of AMG 592.

- Stable dose of non-corticosteroid immunosuppressants for the 2 weeks prior to first
dose of AMG 592.

- Karnofsky performance status score ≥ 50%.

- Adequate bone marrow function indicated by ANC > 1.00 x 109/L and platelets > 50 x
109/L without growth factors or transfusions within the 4 weeks prior to starting AMG
592.

Key Exclusion Criteria:

- Concurrently receiving treatment with calcineurin-inhibitor plus sirolimus (either
agent alone is acceptable).

- Received ibrutinib or following therapies considered investigational for treatment of
cGVHD including imatinib, bortezomib, ruxolitnib, or entospletinib, within 4 wks prior
to starting AMG 592 or is currently receiving treatment in another investigational
drug or device study.

- Treatment with T-cell depleting, B-cell depleting or IL-2 signaling targeted
medication (eg, ATG, alemtuzumab, basiliximab, denileukin diftitox, IL-2, rituximab
within 12wks prior to starting AMG 592.

- Treatment with T regulatory cell expanding therapies (ie ECP, PUVA, UVB, adoptively
transferred T regulatory cells) within 4 wks prior to starting dose of AMG 592.

- Donor lymphocyte infusion within 12 wks prior to starting dose of AMG 592.

- Active morphologic relapse/progression of hematologic malignancy post transplantation.

- History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic
thrombocytopenic purpura.

- Active infection requiring treatment with IV antibiotics or hospitalized for treatment
of an active infection in 4 wks prior to starting dose of AMG 592.

- History of active tuberculosis.

- Hep B and Hep C

- HIV-positive.

- Phase 1b subject has a positive drug or alcohol urine test at screening visit.

- Phase 1b subject is unable to avoid alcohol or tobacco consumption for the duration of
the study.
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