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| Sponsor: | XOMA (US) LLC |
|---|---|
| Information provided by: | XOMA (US) LLC |
| ClinicalTrials.gov Identifier: | NCT00051675 |
Purpose
The purpose of this study is to evaluate the safety, immunogenicity, and tolerability of a monoclonal antibody administered subcutaneously in the treatment of advanced cancers of the ovary, breast, lung, prostate, colon or rectum that are either refractory to standard therapies or for which therapies that may potentially be of major benefit do not exist.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma |
Drug: ING-1(heMAb) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multi-Dose, Phase I, Dose-Escalating Study of a Subcutaneously Administered Human-Engineered Monoclonal Antibody, ING-1(heMAb), in Subjects With Advanced Adenocarcinomas |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Subject has adequate organ function defined as follows:
Hematologic:
Hepatic:
Exclusion Criteria
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00051675 History of Changes |
| Other Study ID Numbers: | INCA104 |
| Study First Received: | January 14, 2003 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma monoclonal antibody |
|
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |