Clinical trial · Interventional
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
NCT01707264CI-TRIAL-00034596completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Amyloidosis | Primary Amyloidosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NEOD001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NEOD001
- description
- 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.
- interventionNames
- Drug: NEOD001
Primary outcomes (2)
- measure
- Safety and tolerability
- timeFrame
- 28 day cycles, up to 1 year; beyond 1 year with approval of Sponsor and Investigator
- description
- * Adverse event profile * Dose limiting toxicity and maximum tolerated dose
- measure
- Maximum tolerated dose
- timeFrame
- 28 day cycles, up to 1 year; beyond 1 year with approval of Sponsor and Investigator
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males and females aged ≥18 years; 2. ECOG performance status (PS) 0-2; 3. Diagnosis of systemic AL amyloidosis (subjects with non-AL amyloidosis are not eligible); 4. Received at least one prior systemic therapy, which may include stem cell transplant, for AL amyloidosis; 5. Have adequate organ function; 6. Ability to understand and willingness to sign informed consent prior to initiation of any study procedures. Exclusion Criteria: 1. Secondary or familial amyloidosis; 2. Life expectancy of \< 3 months; 3. Symptomatic multiple myeloma; 4. Hypersensitivities to other monoclonal antibodies; 5. Known HIV infection; 6. Women who are lactating; 7. Any other condition or prior therapy, which in the opinion of the PI, would make the subject unsuitable for the study.
References
Publications (1)
- DERIVEDGertz MA, Landau H, Comenzo RL, Seldin D, Weiss B, Zonder J, Merlini G, Schonland S, Walling J, Kinney GG, Koller M, Schenk DB, Guthrie SD, Liedtke M. First-in-Human Phase I/II Study of NEOD001 in Patients With Light Chain Amyloidosis and Persistent Organ Dysfunction. J Clin Oncol. 2016 Apr 1;34(10):1097-103. doi: 10.1200/JCO.2015.63.6530. Epub 2016 Feb 8. PMID 26858336