Study Complete
Sponsor ID
20170533

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma

Sponsor ID
20170533
Clinicaltrials.gov ID
NCT03571828
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose [RP2D])

Additional Study Details

Phase
Phase 1
Product
AMG 562
Type
Interventional
Masking
None (Open Label)
Enrollment
10
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of dose limiting toxicities (DLTs)

Timeframe: up to 2 years

Incidence of treatment-emergent adverse events

Timeframe: up to 2 years

Incidence of treatment-related adverse events

Timeframe: up to 2 years

Incidence of disease-related events

Timeframe: up to 2 years

Incidence of clinically-significant changes in vital signs

Timeframe: up to 2 years

Incidence of clinically-significant changes in physical examinations

Timeframe: up to 2 years

Incidence of clinically-significant changes in electrocardiograms (ECG)s

Timeframe: up to 2 years

Incidence of clinically-significant changes in clinical laboratory tests

Timeframe: up to 2 years

Secondary Outcome Measures

Maximum observed concentration (Cmax) of AMG 562

Timeframe: Day 1, 8, 15, 22

minimum concentration (Cmin)

Timeframe: Day 1, 8, 15, 22

time of maximum concentration (Tmax)

Timeframe: Day 1, 8, 15, 22

area under the concentration-time curve (AUC)

Timeframe: Day 1, 8, 15, 22

Half Life (t1/2)

Timeframe: Day 1, 8, 15, 22

Efficacy-Overall Response

Timeframe: Week 5, 15, 20, 25 and EoT

Efficacy-Objective Response Rate (ORR)

Timeframe: Week 5, 15, 20, 25 and EoT

Efficacy-Duration of Response (DOR)

Timeframe: Week 5, 15, 20, 25 and EoT

Efficacy-Progression Free Survival (PFS)

Timeframe: Week 5, 15, 20, 25 and EoT

Efficacy-Overall Survival (OS)

Timeframe: Week 5, 15, 20, 25 and EoT

Locations

Location
Status
Contact Us
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Completed
Location
University of California Los Angeles
Los Angeles, CA, United States, 90095
Status
Recruiting
Location
Klinikum der Universität München Campus Großhadern
München, Germany, 81377
Status
Completed
Location
Washington University
St Louis, MO, United States, 63110
Status
Recruiting
Location
Princess Margaret Cancer Centre
Toronto, ON, Canada, M5G 2M9
Status
Completed
Location
University of Maryland Greenebaum Cancer Center
Baltimore, MD, United States, 21201
Status
Completed
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