Metastatic Colorectal CancerPhase 1/2NCT01605318
Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer
A Phase 1/2 study testing Labetuzumab Govitecan (LG) in people with Metastatic Colorectal Cancer and Colon Cancer, run by Gilead Sciences at 7 sites in United States.
Trial summary
The goal of this clinical study is to determine the dosing and safety of labetuzumab govitecan (formerly known as IMMU-130; hMN-14-SN38, antibody-drug conjugate) in participants with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- What is being tested?
- Labetuzumab Govitecan (LG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Feb 2013to 3 Jan 2017
- Phase
- Phase 1/2
- 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
- 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 (Eastern Cooperative Oncology Group (ECOG) 0 or 1).
- Expected survival > 6 months.
- Carcinoembryonic antigen (CEA) plasma levels > 5 ng/mL.
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- Measurable disease by computed tomography (CT) or Magnetic resonance imaging (MRI).
- At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities.
- At least 2 weeks beyond corticosteroids.
- Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
- Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
- Otherwise, all toxicity at study entry ≤ Grade 1 by National cancer institute common terminology criteria for adverse events (NCI CTC) v4.0.
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.
- Individuals with Gilbert's disease or known central nervous system (CNS) metastatic disease.
- Individuals with CEA plasma levels > 1000 ng/mL must be approved in advance by the Sponsor.
- Presence of bulky disease (defined as any single mass > 10 cm in its greatest dimension).
- Individuals with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
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- Individuals with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while individuals with other prior malignancies must have had at least a 3-year disease-free interval.
- Individuals known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.
- Known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
- Known history of clinically significant active chronic obstructive pulmonary disease (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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43202
IUHealth Goshen Center for Cancer Care
Goshen, Indiana, 46526
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
Helen F. Graham Cancer Center-Christiana Care
Newark, Delaware, 19713
Fox Chase
Philadelphia, Pennsylvania, 19111
UCLA Jonsson Comprehensive Cancer Center
Santa Monica, California, 90404
About this study
Official title: A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer
The goal of this clinical study is to determine the dosing and safety of labetuzumab govitecan (formerly known as IMMU-130; hMN-14-SN38, antibody-drug conjugate) in participants with colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- Being tested
- Labetuzumab Govitecan (LG)
- Keywords
- Previously treated Metastatic colorectal cancer, Previously treated Colon cancer, Previously treated Rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labetuzumab Govitecan (LG)Drug
Also called hMN14-SN38, Labetuzumab-SN38, Antibody-Drug Conjugate, IMMU-0130
Administered as a slow intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase1: Dose-escalation Phase: Labetuzumab Govitecan (LG) Once Weekly Dosing | Experimental | Participants will receive 8, 12 and 16 mg/dose of LG once weekly dosing until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to up to 8 cycles, with a contingency to examine intermediate dose levels of 10 or 14 mg/kg, or if necessary to a lower dose level of 6 mg/kg. Receives: Drug: Labetuzumab Govitecan (LG) |
| Phase1: Dose-escalation Phase: LG Twice Weekly Dosing | Experimental | Participants will receive 6 and 9 mg/kg per dose twice weekly dose of LG until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to up to 8 cycles. A lower dose level of 4 mg/kg may be added if > 1 out of 3 or 2 out of 6 participants are unable to tolerate all 4 doses without dose delay or reduction. Receives: Drug: Labetuzumab Govitecan (LG) |
| Phase 2: Dose-expansion Phase: LG Once or Twice Weekly Dosing | Experimental | Participants will receive selected doses of LG once or twice weekly until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to 8 cycles. Receives: Drug: Labetuzumab Govitecan (LG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events and Serious Adverse Events (SAEs)
Measured: From first dose date up to approximately 2 years after the last dose or until disease progression
Percentage of Participants With Laboratory Abnormalities
Measured: From first dose date up to approximately 2 years after the last dose or until disease progression
Secondary outcomes (6)
Duration of Response
Duration of response (DOR) is defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression (PD) or death from any cause.
Measured: From first documentation of PR or CR to the earlier of the first documentation of PD or death from any cause (Up to approximately 2 years after the last dose or until disease progression)
Progression-free Survival
Progression free survival (PFS) is defined as the interval from the start of study drug treatment to the earlier of the first documentation of disease progression or death from any cause.
Measured: From first dose date up to 12 weeks post treatment (Up to approximately 2 years after the last dose or until disease progression)
Time to Progression
Time to progression is defined as the interval from the first dose of treatment to the first documentation of disease progression (PD).
Measured: From first dose of study treatment up to PD (Up to approximately 2 years after the last dose or until disease progression)
Overall Survival
Overall survival is defined as the time from start of study drug treatment to death from any cause.
Measured: From first dose date up to approximately 2 years
Time-to-treatment Failure
Time to treatment failure (TTF) is defined as the interval from the start of treatment to the earlier of the first documentation of disease progression or death due to any cause, the permanent cessation of LG therapy due to all reasons except progressive disease, participant died or lost to follow up.
Measured: From first dose date up to 8 treatment cycles (each cycle = 21 days) (Up to approximately 24 weeks)
Change from Baseline in Carcinoembryonic Antigen (CEA) Serum Levels
Measured: From first dose date up to approximately 2 years after the last dose or until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study start12 Feb 2013
- Primary completion3 Jan 2017
- Study completion3 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605318
- Sponsor's protocol ID
- IMMU-130-02
- Status last verified
- Jan 2024
- First submitted
- 22 May 2012
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Govindan SV, Goldenberg DM. New antibody conjugates in cancer therapy. ScientificWorldJournal. 2010 Oct 12;10:2070-89. doi: 10.1100/tsw.2010.191.
PubMed 20953556Govindan SV, Cardillo TM, Moon SJ, Hansen HJ, Goldenberg DM. CEACAM5-targeted therapy of human colonic and pancreatic cancer xenografts with potent labetuzumab-SN-38 immunoconjugates. Clin Cancer Res. 2009 Oct 1;15(19):6052-61. doi: 10.1158/1078-0432.CCR-09-0586. Epub 2009 Sep 29.
PubMed 19789330Moon SJ, Govindan SV, Cardillo TM, D'Souza CA, Hansen HJ, Goldenberg DM. Antibody conjugates of 7-ethyl-10-hydroxycamptothecin (SN-38) for targeted cancer chemotherapy. J Med Chem. 2008 Nov 13;51(21):6916-26. doi: 10.1021/jm800719t. Epub 2008 Oct 22.
PubMed 18939816Govindan SV, Griffiths GL, Hansen HJ, Horak ID, Goldenberg DM. Cancer therapy with radiolabeled and drug/toxin-conjugated antibodies. Technol Cancer Res Treat. 2005 Aug;4(4):375-91. doi: 10.1177/153303460500400406.
PubMed 16029057Dotan E, Cohen SJ, Starodub AN, Lieu CH, Messersmith WA, Simpson PS, Guarino MJ, Marshall JL, Goldberg RM, Hecht JR, Wegener WA, Sharkey RM, Govindan SV, Goldenberg DM, Berlin JD. Phase I/II Trial of Labetuzumab Govitecan (Anti-CEACAM5/SN-38 Antibody-Drug Conjugate) in Patients With Refractory or Relapsing Metastatic Colorectal Cancer. J Clin Oncol. 2017 Oct 10;35(29):3338-3346. doi: 10.1200/JCO.2017.73.9011. Epub 2017 Aug 17.
PubMed 28817371
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01605318
- Acronym / sponsor ID
- IMMU-130-02
- Conditions
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- Keywords
- Previously treated Metastatic colorectal cancer, Previously treated Colon cancer, Previously treated Rectal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2013 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 24 May 2012 (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.
The goal of this clinical study is to determine the dosing and safety of labetuzumab govitecan (formerly known as IMMU-130; hMN-14-SN38, antibody-drug conjugate) in participants with colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase1: Dose-escalation Phase: Labetuzumab Govitecan (LG) Once Weekly Dosing | Experimental | Drug: Labetuzumab Govitecan (LG)Participants will receive 8, 12 and 16 mg/dose of LG once weekly dosing until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to up to 8 cycles, with a contingency to examine intermediate dose levels of 10 or 14 mg/kg, or if necessary to a lower dose level of 6 mg/kg. |
| Phase1: Dose-escalation Phase: LG Twice Weekly Dosing | Experimental | Drug: Labetuzumab Govitecan (LG)Participants will receive 6 and 9 mg/kg per dose twice weekly dose of LG until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to up to 8 cycles. A lower dose level of 4 mg/kg may be added if > 1 out of 3 or 2 out of 6 participants are unable to tolerate all 4 doses without dose delay or reduction. |
| Phase 2: Dose-expansion Phase: LG Once or Twice Weekly Dosing | Experimental | Drug: Labetuzumab Govitecan (LG)Participants will receive selected doses of LG once or twice weekly until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to 8 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 (Eastern Cooperative Oncology Group (ECOG) 0 or 1).
- Expected survival > 6 months.
Key exclusion criteria (12 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.
- Individuals with Gilbert's disease or known central nervous system (CNS) metastatic disease.
- Individuals with CEA plasma levels > 1000 ng/mL must be approved in advance by the Sponsor.
- Presence of bulky disease (defined as any single mass > 10 cm in its greatest dimension).
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 |
|---|---|---|
| Labetuzumab Govitecan (LG)Also: hMN14-SN38, Labetuzumab-SN38, Antibody-Drug Conjugate, IMMU-0130Administered as a slow intravenous (IV) infusion. | Drug | Phase 2: Dose-expansion Phase: LG Once or Twice Weekly Dosing, Phase1: Dose-escalation Phase: LG Twice Weekly Dosing, Phase1: Dose-escalation Phase: Labetuzumab Govitecan (LG) Once Weekly Dosing |
Primary outcome
Percentage of Participants With Adverse Events and Serious Adverse Events (SAEs)
Time frame: From first dose date up to approximately 2 years after the last dose or until disease progression
Percentage of Participants With Laboratory Abnormalities
Time frame: From first dose date up to approximately 2 years after the last dose or until disease progression
6 secondary outcomes
Duration of Response
Time frame: From first documentation of PR or CR to the earlier of the first documentation of PD or death from any cause (Up to approximately 2 years after the last dose or until disease progression)
Progression-free Survival
Time frame: From first dose date up to 12 weeks post treatment (Up to approximately 2 years after the last dose or until disease progression)
Time to Progression
Time frame: From first dose of study treatment up to PD (Up to approximately 2 years after the last dose or until disease progression)
Overall Survival
Time frame: From first dose date up to approximately 2 years
Time-to-treatment Failure
Time frame: From first dose date up to 8 treatment cycles (each cycle = 21 days) (Up to approximately 24 weeks)
Change from Baseline in Carcinoembryonic Antigen (CEA) Serum Levels
Time frame: From first dose date up to approximately 2 years after the last dose or until disease progression
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Background: PubMed 20953556Govindan SV, Goldenberg DM. New antibody conjugates in cancer therapy. ScientificWorldJournal. 2010 Oct 12;10:2070-89. doi: 10.1100/tsw.2010.191.
- Background: PubMed 19789330Govindan SV, Cardillo TM, Moon SJ, Hansen HJ, Goldenberg DM. CEACAM5-targeted therapy of human colonic and pancreatic cancer xenografts with potent labetuzumab-SN-38 immunoconjugates. Clin Cancer Res. 2009 Oct 1;15(19):6052-61. doi: 10.1158/1078-0432.CCR-09-0586. Epub 2009 Sep 29.
- Background: PubMed 18939816Moon SJ, Govindan SV, Cardillo TM, D'Souza CA, Hansen HJ, Goldenberg DM. Antibody conjugates of 7-ethyl-10-hydroxycamptothecin (SN-38) for targeted cancer chemotherapy. J Med Chem. 2008 Nov 13;51(21):6916-26. doi: 10.1021/jm800719t. Epub 2008 Oct 22.
- Background: PubMed 16029057Govindan SV, Griffiths GL, Hansen HJ, Horak ID, Goldenberg DM. Cancer therapy with radiolabeled and drug/toxin-conjugated antibodies. Technol Cancer Res Treat. 2005 Aug;4(4):375-91. doi: 10.1177/153303460500400406.
- Background: PubMed 28817371Dotan E, Cohen SJ, Starodub AN, Lieu CH, Messersmith WA, Simpson PS, Guarino MJ, Marshall JL, Goldberg RM, Hecht JR, Wegener WA, Sharkey RM, Govindan SV, Goldenberg DM, Berlin JD. Phase I/II Trial of Labetuzumab Govitecan (Anti-CEACAM5/SN-38 Antibody-Drug Conjugate) in Patients With Refractory or Relapsing Metastatic Colorectal Cancer. J Clin Oncol. 2017 Oct 10;35(29):3338-3346. doi: 10.1200/JCO.2017.73.9011. Epub 2017 Aug 17.
- Individual participant dataSharing planned: No
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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.
Gilead Study Director study director
Gilead Sciences
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Labetuzumab Govitecan (LG) in people with Metastatic Colorectal Cancer and Colon Cancer, run by Gilead Sciences at 7 sites in United States.
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 12 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: stopped early, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early. Results are not available in the source record.
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?
Percentage of Participants With Adverse Events and Serious Adverse Events (SAEs) (time frame: From first dose date up to approximately 2 years after the last dose or until disease progression). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01605318, which also lists 5 linked publications.
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 24 Jan 2024.