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A Phase 1b/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 592 in Adult Subjects With Steroid Refractory Chronic Graft versus Host Disease
The purpose of Phase 1b is to evaluate the safety and tolerability of multiple ascending doses of AMG 592 in participants with steroid refractory cGVHD. The purpose of Phase 2 is to evaluate the efficacy of AMG 592 in participants with steroid refractory cGVHD as measured by ORR at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria.
Primary: Phase 1b : To evaluate the safety and tolerability of multiple ascending doses of AMG 592 in subjects with steroid refractory cGVHD in order to estimate the MTD and establish the RP2D. Phase 2 :To evaluate the efficacy of AMG 592 in subjects with steroid refractory cGVHD as measured by the best overall response rate (ORR) during the study according to the 2014 cGVHD National Institutes of Health (NIH) Consensus Criteria. Secondary: Phase 1b :To evaluate the immunologic effects of AMG 592 including fold change from baseline in regulatory T cell (Treg), conventional T cell (Tcon), and NK cell numbers (cells/ìL) and the Treg/Tcon ratio. To characterize the PK profile following multiple ascending subcutaneous (SC) dose administrations of AMG 592. To evaluate the incidence of anti-AMG 592 antibody formation and cross-reactivity to native human interleukin-2 (IL-2). Phase 2: To evaluate the safety and tolerability of AMG 592 as measured by the occurrence of treatment-emergent adverse events. To evaluate ORR, as defined by 2014 cGVHD NIH Consensus Criteria at various timepoints in AMG 592- treated subjects. To evaluate failure free survival (FFS), defined as absence of relapse, death, or need for additional systemic immunosuppressant cGVHD therapy. To evaluate systemic steroid use. To evaluate changes in symptom burden as measured by the Lee Symptom Scale. To measure changes in quality of life as measured by Short Form Health Survey 36 version 2 (SF36v2) and Karnofsky performance status. To evaluate the PK of AMG 592. To evaluate the incidence of anti-AMG 592 antibody formation and cross reactivity to human IL-2.