Clinical trial · Interventional
A Phase I Study of BIIB015 in Relapsed/Refractory Solid Tumors
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
NCT00674947CI-TRIAL-00012080completedPhase 1ClinicalTrials.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)
Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIIB015 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To evaluate safety
- timeFrame
- ongoing
- measure
- To determine the maximum-tolerated dose (MTD)
- timeFrame
- ongoing
Secondary outcomes (2)
- measure
- To evaluate pharmacokinetics (PK)
- timeFrame
- ongoing
- measure
- To evaluate clinical activity
- timeFrame
- ongoing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \</= 2. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.