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
- 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 = 2.
- 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:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate safety
Outcome Time Frame:
United States: Food and Drug Administration
- Solid Tumors