Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00105170

Enrollment

Registered

2005-03-09

Start date

2005-01-31

Completion date

2006-08-31

Last updated

2013-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumors

Keywords

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

Brief summary

This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.

Interventions

DRUGhCBE-11

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors	up to 2 years

Secondary

Measure	Time frame
To define the recommended Phase II dose of hCBE-11	up to 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026