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A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors


Inclusion Criteria:



- Relapsed or refractory solid tumors not curable with standard therapy.

- At least one measurable lesion

- ECOG Performance Status less than or equal to 2

- Acceptable hematologic status

- Albumin greater than or equal to 2.5 g/dL

- Normal calculated glomerular filtration rate (GFR)

- Acceptable liver function

Exclusion Criteria:

- Uncontrolled cardiac disease, angina, congestive heart failure, or myocardial
infarction within 6 months prior to Study Day

- Known history of hepatitis B or C, or HIV infection

- Clinically significant effusions, including pericardial, pleural, and ascites

- Serious non-malignant disease

- Central nervous system (CNS) metastatic involvement except where the disease has been
successfully treated

- Investigational therapies within 4 weeks of Study Day 1

- Radiation therapy of tumors to be followed for this study

- Chemotherapy, biologic therapy, or major surgery other than diagnostic within 4 weeks
prior to Study Day 1

- Current Grade 3 or 4 neurological toxicity

- Concurrent anti-neoplastic therapy and/or steroids

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors

Outcome Time Frame:

up to 2 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

202-01

NCT ID:

NCT00105170

Start Date:

January 2005

Completion Date:

August 2006

Related Keywords:

  • Tumors
  • Monoclonal antibody
  • Advanced solid tumors
  • Tumors
  • hCBE-11

Name

Location

Research SiteMesa, Arizona  
Research SiteBoulder, Colorado  
Research SiteAllentown, Pennsylvania