A Phase I Study of BIIB015, a Humanized, IgG1, DM4-Conjugated, Anti-Cripto, Monoclonal Antibody, for the Treatment of Subjects With Relapsed or Refractory Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Solid Tumors
Both
Solid Tumors
Trial Information
A Phase I Study of BIIB015, a Humanized, IgG1, DM4-Conjugated, Anti-Cripto, Monoclonal Antibody, for the Treatment of Subjects With Relapsed or Refractory Solid Tumors
Inclusion Criteria
Inclusion Criteria
- Age 18 years or older at the time of informed consent.
- Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic
therapy and for which no standard therapy exists.
- ECOG Performance Status
Exclusion Criteria
- History of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction within 6 months prior to Day 1.
- Presence of >/= Grade 2 peripheral neuropathy.
- Known presence of central nervous system or brain metastases.
- Prior therapy with a conjugated or unconjugated maytansine derivative.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate safety
Outcome Time Frame:
ongoing
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
207ST101
NCT ID:
NCT00674947
Start Date:
June 2008
Completion Date:
June 2011
Related Keywords:
- Solid Tumors
- Relapsed
- Refractory
- Neoplasms
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Allentown, Pennsylvania |
| Research Site | Abilene, Texas |
