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Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00041652
Enrollment
30
Registered
2002-07-15
Start date
2000-02-29
Completion date
2003-06-30
Last updated
2021-08-19

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

Conditions

Breast Cancer, Breast Neoplasms, Colon Cancer, Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms, Rectal Cancer

Keywords

Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Breast Cancer, Breast Neoplasms

Brief summary

The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer.

Interventions

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

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
No

Inclusion criteria

Disease Characteristics: * Histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma * Measurable lesion diagnosed by CT scan * Recurrent/metastatic disease considered surgically unresectable. Prior/Concurrent Therapy: * Chemotherapy: Patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (Enrollment must occur at least 4 weeks beyond last treatment) * Other: Prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study Patient Characteristics/Inclusion Criteria: * Performance Status: Patients with a Karnofsky performance status \> 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months. * Hematopoietic: WBC \>/= 3000 mm3, neutrophils \>/= 1500 mm3, platelets \>/= 75,000, CEA \< 300 ng/mL * Hepatic: Serum bilirubin \</= 2.0 mg/dL, ALT \< 2.5 x IULN * Cardiovascular: Patients with LVEF \>/= 40% by required MUGA/2D-ECHO study. * Pulmonary: Patients with FEV1 \>/= 60% by required Pulmonary Function Tests * Other: Patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent. Patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.

Countries

United States

Outcome results

None listed

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