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A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer

A Phase II Study of IMMU 130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Metastatic Colorectal Cancer

NCT01915472•Gilead Sciences

Summary

This is a Phase II trial to study the safety and efficacy of IMMU-130. IMMU-130 is composed of a drug attached to an antibody. The drug is the active ingredient in irinotecan which is a common chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by the immune system. They bind to substances that don't belong in the body to prevent harm to the body. The antibody in this study was designed to bind to a marker located on colorectal cancer tumors. The antibody was originally made from mouse proteins, but was changed in the laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is safe and effective.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients, ≥ 18 years of age, able to understand and give written informed consent
•Histologically or cytologically confirmed colorectal adenocarcinoma
•Stage IV (metastatic) disease
•Previously treated with at least one prior irinotecan-containing regimen for colorectal cancer
•Adequate performance status (ECOG 0 or 1) (Appendix 1)
•Expected survival ≥ 6 months
•CEA plasma levels \> 5 ng/mL
•Measurable disease by CT or MRI, but with no single lesion measuring more than 10.0 cm
•At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities
•Adequate hematology without ongoing transfusional support (hemoglobin \> 8 g/dL, ANC ≥ 1,500 per mm3, platelets \> 100,000 per mm3)
+2 more criteria

Exclusion Criteria

•Women who are pregnant or lactating.
•Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
•Patients with Gilbert's disease or known CNS metastatic disease. However, patients with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided that they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new enlarging CNS metastasis, (2) off steroids or on a stable dose of steroids.
•Patients with CEA plasma levels \> 1000 ng/mL must be approved in advance by the Sponsor.
•Patients with active ≥ Grade 3 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
•Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval, or are deemed at low risk for recurrence by his/her treating physician.
•Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
•Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
•Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
•Infection requiring intravenous antibiotic use within 1 week.
+1 more criteria

Key Dates

Start Date

September 1, 2013

Primary Completion Date

August 1, 2015

Completion Date

August 1, 2015

Last Updated

August 19, 2021

Conditions

Metastatic Colorectal Cancer

Interventions

IMMU 130

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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