Metastatic Colorectal CancerPhase 2NCT01915472
A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing IMMU 130 in people with Metastatic Colorectal Cancer, run by Gilead Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- IMMU 130
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
- Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin within normal limits, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases)
- Otherwise, all acute toxicity at study entry ≤ Grade 1 by NCI CTC v4.0, or recovered to baseline
Who cannot join
- 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.
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- 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.
- Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
About this study
Official title: A Phase II Study of IMMU 130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Metastatic Colorectal Cancer
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- IMMU 130
- Keywords
- Metastatic Colorectal Cancer, Colorectal Cancer, Rectal Cancer, previously treated
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMMU 130Drug
Also called hMN14-SN38, Labetuzumab-SN38, antibody-drug conjugate
This is a Phase II, open-label study of IMMU-130 administered every 14 days for a period of 24 weeks to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen.
| Study group | Role | What they receive |
|---|---|---|
| IMMU 130 | Experimental | Not described Receives: Drug: IMMU 130 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The primary outcome measured will be safety of IMMU-130 administered at different dose levels. Safety will be assessed by reviewing the number of adverse events and overall toxicity.
Measured: Safety will be measured routinely during the 6 months of administration and afterwards during follow-up for up to 5 years
Secondary outcomes (1)
Assess PK
The secondary objectives are to assess pharmacokinetics and immunogenicity, and to obtain preliminary information on efficacy with this dosing schedule. Efficacy will be assessed using CT scan imaging.
Measured: Efficacy will be measured every 8 weeks during treatment and every 3 months during the 1st year and then every 6 months up to 5 years thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915472
- Sponsor's protocol ID
- IMMU 130-03
- Status last verified
- Dec 2020
- First submitted
- 1 Aug 2013
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of IMMU 130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01915472
- Acronym / sponsor ID
- IMMU 130-03
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer, Colorectal Cancer, Rectal Cancer, previously treated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2013 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMMU 130 | Experimental | Drug: IMMU 130 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMMU 130Also: hMN14-SN38, Labetuzumab-SN38, antibody-drug conjugateThis is a Phase II, open-label study of IMMU-130 administered every 14 days for a period of 24 weeks to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen. | Drug | IMMU 130 |
Primary outcome
Safety
Time frame: Safety will be measured routinely during the 6 months of administration and afterwards during follow-up for up to 5 years
The primary outcome measured will be safety of IMMU-130 administered at different dose levels. Safety will be assessed by reviewing the number of adverse events and overall toxicity.
1 secondary outcome
Assess PK
Time frame: Efficacy will be measured every 8 weeks during treatment and every 3 months during the 1st year and then every 6 months up to 5 years thereafter.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMMU 130 in people with Metastatic Colorectal Cancer, run by Gilead Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Safety will be measured routinely during the 6 months of administration and afterwards during follow-up for up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.