20170533 (AMG562 fase I)
A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With Relapsed / Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
- Experimental: dose exploration: dose exploration cohorts to estimate the MTD, safety, tolerability, PK, and PD of different doses of AMG 562
- Experimental: dose expansion: dose expansion part to gain further clinical experience, safety and efficacy data for AMG 562
- Age ≥ 18 years
- Diagnosis of mantle cell lymphoma
- Refractory (no prior CR/CMR) to first or later line of treatment or relapsed (prior CR/CMR) after three or more prior treatments, with at least one treatment consisting of a standard chemotherapy containing an approved anti-CD20 agent.
- Radiographically measurable disease with a clearly demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension
- ECOG score ≤ 2
- Treatment within 30 days prior to enrollment with another investigational device or drug
- Prior anti-CD19-directed therapies.
- Prior allogeneic HSCT
- Baseline electrocardiogram (ECG) QTc > 470 msec
- University Hospital Leuven Gasthuisberg