Trial | NCT01707264  Report issue

Title

Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
A Phase 1/2, Open Label, Dose Escalation Study of Intravenous Administration of Single Agent NEOD001 in Subjects With Light Chain (AL) Amyloidosis

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    neod001 ...

  • Study Participants

    69
Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.
The purpose of the dose escalation phase of the study is to determine the maximum tolerated dose/Phase 2 recommended dose of NEOD001 when given as a single agent intravenously in approximately 30 subjects with AL amyloidosis.

The purpose of the expansion phase of the study is to evaluate the safety, preliminary efficacy and pharmacokinetics of single agent NEOD001 at the maximum tolerated dose/Phase 2 recommended dose in approximately 25 additional evaluable subjects.
Study Started
Apr 30
2013
Primary Completion
Aug 09
2016
Study Completion
Aug 09
2016
Last Update
Aug 28
2018

Drug NEOD001

Monoclonal antibody administered by intravenous infusion every 28 days.

NEOD001 Experimental

NEOD001 will be administered intravenously once every 28 days. The starting dose will be 0.5 mg/kg. Dose escalation will continue until the the maximum tolerated dose is determined for single agent NEOD001. Approximately 20 additional subjects will be treated with the maximum tolerated dose.

Criteria 

Inclusion Criteria:

Males and females aged ≥18 years;
ECOG performance status (PS) 0-2;
Diagnosis of systemic AL amyloidosis (subjects with non-AL amyloidosis are not eligible);
Received at least one prior systemic therapy, which may include stem cell transplant, for AL amyloidosis;
Have adequate organ function;
Ability to understand and willingness to sign informed consent prior to initiation of any study procedures.

Exclusion Criteria:

Secondary or familial amyloidosis;
Life expectancy of < 3 months;
Symptomatic multiple myeloma;
Hypersensitivities to other monoclonal antibodies;
Known HIV infection;
Women who are lactating;
Any other condition or prior therapy, which in the opinion of the PI, would make the subject unsuitable for the study.
No Results Posted