Metastatic Colorectal CancerPhase 1NCT01273402

Study of TF2 Carcinoembryonic Antigen (CEA) Antibody in Patients With Metastatic Colorectal Cancer

A Phase 1 study testing TF2/IMP288 in people with Metastatic Colorectal Cancer, run by Gilead Sciences at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study is being done to select an appropriate TF2 bsMAb dose suitable for pretargeting the 111In/90Y-labeled hapten-peptide (IMP-288). Eligible patients will receive a fixed dose of 90Y-IMP-288 4 days after the TF2 antibody injection. Two different dose levels of TF2 will be studied in the first part. 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?: TF2/IMP288
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Feb 2011to Aug 2018
Phase: Phase 1
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.
documented histologic or cytologic diagnosis of metastatic (Stage IV) colorectal cancer.
must have at least one confirmed and measurable tumor lesion (a confirmed tumor site is one in which either biopsy-proven evidence of disease or progressive growth has been radiographically observed).
Patients must have failed standard therapy or for whom no standard therapy exists.
Patients must have a Karnofsky performance status of ≥ 70% (or equivalent ECOG 0-1) and an expected survival of ≥ 3 months.
Patients who previously received a chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant anti-antibody reactivity with TF2.

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Hematologic parameters: WBC counts must be ≥ 3000/mm3, granulocytes
1500/mm3, and platelets ≥ 100,000/m3.
Non-hematologic parameters: Patients without liver metastases must have bilirubin ≤ 1.5 institutional upper limit of normal (IULN), whereas bilirubin in patients with known liver metastases must be <2.5-times the IULN. AST/ALT must not be >2.5 times IULN.
At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis.
Patients able to understand and give written informed consent. Informed consent must be obtained prior to baseline studies for enrollment purposes.

Who cannot join

Women who are pregnant or lactating. Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this trial and will be advised that they must use effective contraception during and for a period of 3 months.
Patients with plasma CEA >1000 ng/mL or lesions exceeding 10 cm in diameter.
Patients with severe anorexia or other gastrointestinal-related symptomatology (e.g., nausea, vomiting).
Patients with known HIV or hepatitis B or C.
Patients with an active second primary malignancy at the time of study entry, with the exception of carcinoma in situ of the cervix.
Patients with known metastatic disease to the central nervous system.

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Patients with evidence of bone marrow metastases. Screening only required for patients with suspicion of metastases. Patients with ≥ 25% bone marrow involvement are excluded.
Patients who are, in the opinion of the investigator, unable to comply with the protocol requirements.
Institutionalized subjects (e.g., prisons, psychiatric facilities).
Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy.
Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids); or infection requiring intravenous antibiotic use within 1 week.
Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months.
Patients who are diabetic and/or have high blood pressure are at a higher risk for developing late-stage renal failure. While these patients will not be specifically excluded, physician-investigators must carefully discuss the associated late risks to these patients.
Patients must be at least 4 weeks beyond prior chemotherapy, surgery, radiotherapy to an index lesion, or experimental therapy (i.e., drugs, biologicals, procedures) and meet all eligibility criteria.
Patients who received a treatment containing a nitrosourea compound will not be enrolled for at least 6 weeks after the end of that treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

Georgetown University Medical Center
Washington D.C., District of Columbia, 20057

Other trials in United States

About this study

Official title: Pretargeted Radioimmunotherapy of Colorectal Cancer: A Phase I Study to Determine Dose-limiting Toxicity and Maximum Tolerated Dose of an Anti-CEACAM5 bsMAb-pretargeted 90Y-hapten-peptide

Once an appropriate TF2 dose is selected based on information learned from the first 2 dose levels, patients will be enrolled onto several different increasing dose levels of 90Y-IMP-288.

Conditions: Metastatic Colorectal Cancer
Being tested: TF2/IMP288
Keywords: colorectal cancer, TF2 (Recombinant, humanized Tri-Fab bsMAb composed of 2 humanized MN-14 anti-CEA Fab x and one 679 anti-HSG Fab), IMP288 (DOTA-di-HSG hapten-peptide for 111In/90Y labeling)
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TF2/IMP288Drug
Also called TF2, IMP288, bi-specific antibodies, pre-targeted antibodies
TF2 is administered 4 days prior to radiolabeled IMP288. Each are given weekly for 2 weeks.

Study groups in NCT01273402
Study group	Role	What they receive
TF2 and IMP288	Experimental	TF2 will be administered at least 4 days before the radiolabeled IMP-288. Receives: Drug: TF2/IMP288

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine the number of adverse events
Safety will be assessed by determing the number of participants with Adverse Events as a Measure of Safety and Tolerability.
Measured: Safety will be measured routinely during the 3 weeks of administration and afterwards during follow-up for up to 5 years

Secondary outcomes (1)

Efficacy will be evaluating using CT scans and possibly PET imaging.
CT scans will primarily be used to assess tumor response and to assess the change in tumor size from baseline for up to 2 years.
Measured: Efficacy will be measured at 4 and 8 weeks after treatment and every 3 months for up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Aug 2018

First posted10 Jan 2011 (estimated)
Study startFeb 2011
Primary completionFeb 2013
Study completionAug 2018

Why it stopped: A new study is being designed. No patients were enrolled.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01273402
Sponsor's protocol ID: C-072-09 (NCI 5R01CA107088-04)
Other IDs: 5R01CA107088-04
Status last verified: Dec 2020
First submitted: 5 Jan 2011
Last updated: 16 Aug 2021
Results posted: No
Data monitoring committee: No

Publications

Schoffelen R, van der Graaf WT, Franssen G, Sharkey RM, Goldenberg DM, McBride WJ, Rossi EA, Eek A, Oyen WJ, Boerman OC. Pretargeted 177Lu radioimmunotherapy of carcinoembryonic antigen-expressing human colonic tumors in mice. J Nucl Med. 2010 Nov;51(11):1780-7. doi: 10.2967/jnumed.110.079376.
PubMed 21051650
Sharkey RM, Rossi EA, McBride WJ, Chang CH, Goldenberg DM. Recombinant bispecific monoclonal antibodies prepared by the dock-and-lock strategy for pretargeted radioimmunotherapy. Semin Nucl Med. 2010 May;40(3):190-203. doi: 10.1053/j.semnuclmed.2009.12.002.
PubMed 20350628
Chatal JF, Campion L, Kraeber-Bodere F, Bardet S, Vuillez JP, Charbonnel B, Rohmer V, Chang CH, Sharkey RM, Goldenberg DM, Barbet J; French Endocrine Tumor Group. Survival improvement in patients with medullary thyroid carcinoma who undergo pretargeted anti-carcinoembryonic-antigen radioimmunotherapy: a collaborative study with the French Endocrine Tumor Group. J Clin Oncol. 2006 Apr 10;24(11):1705-11. doi: 10.1200/JCO.2005.04.4917. Epub 2006 Mar 20.
PubMed 16549819
Kraeber-Bodere F, Rousseau C, Bodet-Milin C, Ferrer L, Faivre-Chauvet A, Campion L, Vuillez JP, Devillers A, Chang CH, Goldenberg DM, Chatal JF, Barbet J. Targeting, toxicity, and efficacy of 2-step, pretargeted radioimmunotherapy using a chimeric bispecific antibody and 131I-labeled bivalent hapten in a phase I optimization clinical trial. J Nucl Med. 2006 Feb;47(2):247-55.
PubMed 16455630
Kraeber-Bodere F, Faivre-Chauvet A, Ferrer L, Vuillez JP, Brard PY, Rousseau C, Resche I, Devillers A, Laffont S, Bardies M, Chang K, Sharkey RM, Goldenberg DM, Chatal JF, Barbet J. Pharmacokinetics and dosimetry studies for optimization of anti-carcinoembryonic antigen x anti-hapten bispecific antibody-mediated pretargeting of Iodine-131-labeled hapten in a phase I radioimmunotherapy trial. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):3973S-81S.
PubMed 14506196
Kraeber-Bodere F, Goldenberg DM, Chatal JF, Barbet J. Pretargeted radioimmunotherapy in the treatment of metastatic medullary thyroid cancer. Curr Oncol. 2009 Sep;16(5):3-8. doi: 10.3747/co.v16i5.464. No abstract available.
PubMed 19862356
Goldenberg DM, Chatal JF, Barbet J, Boerman O, Sharkey RM. Cancer Imaging and Therapy with Bispecific Antibody Pretargeting. Update Cancer Ther. 2007 Mar;2(1):19-31. doi: 10.1016/j.uct.2007.04.003.
PubMed 18311322
Goldenberg DM, Sharkey RM, Paganelli G, Barbet J, Chatal JF. Antibody pretargeting advances cancer radioimmunodetection and radioimmunotherapy. J Clin Oncol. 2006 Feb 10;24(5):823-34. doi: 10.1200/JCO.2005.03.8471. Epub 2005 Dec 27.
PubMed 16380412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metastatic Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pretargeted Radioimmunotherapy of Colorectal Cancer: A Phase I Study to Determine Dose-limiting Toxicity and Maximum Tolerated Dose of an Anti-CEACAM5 bsMAb-pretargeted 90Y-hapten-peptide
ClinicalTrials.gov ID: NCT01273402
Acronym / sponsor ID: C-072-09 (NCI 5R01CA107088-04)
Conditions: Metastatic Colorectal Cancer
Keywords: colorectal cancer, TF2 (Recombinant, humanized Tri-Fab bsMAb composed of 2 humanized MN-14 anti-CEA Fab x and one 679 anti-HSG Fab), IMP288 (DOTA-di-HSG hapten-peptide for 111In/90Y labeling)
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: A new study is being designed. No patients were enrolled.
Enrolment: 0 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Collaborators: National Cancer Institute (NCI)
Study start: Feb 2011 (actual)
Primary completion: Feb 2013 (actual)
Study completion: Aug 2018 (actual)
First posted: 10 Jan 2011 (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.

Once an appropriate TF2 dose is selected based on information learned from the first 2 dose levels, patients will be enrolled onto several different increasing dose levels of 90Y-IMP-288.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TF2 and IMP288	Experimental	Drug: TF2/IMP288TF2 will be administered at least 4 days before the radiolabeled IMP-288.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male or female patients, >18 years of age.
documented histologic or cytologic diagnosis of metastatic (Stage IV) colorectal cancer.
must have at least one confirmed and measurable tumor lesion (a confirmed tumor site is one in which either biopsy-proven evidence of disease or progressive growth has been radiographically observed).
Patients must have failed standard therapy or for whom no standard therapy exists.
Patients must have a Karnofsky performance status of ≥ 70% (or equivalent ECOG 0-1) and an expected survival of ≥ 3 months.

Key exclusion criteria (15 listed)

Women who are pregnant or lactating. Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this trial and will be advised that they must use effective contraception during and for a period of 3 months.
Patients with plasma CEA >1000 ng/mL or lesions exceeding 10 cm in diameter.
Patients with severe anorexia or other gastrointestinal-related symptomatology (e.g., nausea, vomiting).
Patients with known HIV or hepatitis B or C.
Patients with an active second primary malignancy at the time of study entry, with the exception of carcinoma in situ of the cervix.

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
TF2/IMP288Also: TF2, IMP288, bi-specific antibodies, pre-targeted antibodiesTF2 is administered 4 days prior to radiolabeled IMP288. Each are given weekly for 2 weeks.	Drug	TF2 and IMP288

Primary outcome

Determine the number of adverse events
Time frame: Safety will be measured routinely during the 3 weeks of administration and afterwards during follow-up for up to 5 years
Safety will be assessed by determing the number of participants with Adverse Events as a Measure of Safety and Tolerability.

1 secondary outcome

Efficacy will be evaluating using CT scans and possibly PET imaging.
Time frame: Efficacy will be measured at 4 and 8 weeks after treatment and every 3 months for up to 2 years.

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 16 Aug 2021.
Background: PubMed 21051650Schoffelen R, van der Graaf WT, Franssen G, Sharkey RM, Goldenberg DM, McBride WJ, Rossi EA, Eek A, Oyen WJ, Boerman OC. Pretargeted 177Lu radioimmunotherapy of carcinoembryonic antigen-expressing human colonic tumors in mice. J Nucl Med. 2010 Nov;51(11):1780-7. doi: 10.2967/jnumed.110.079376.
Background: PubMed 20350628Sharkey RM, Rossi EA, McBride WJ, Chang CH, Goldenberg DM. Recombinant bispecific monoclonal antibodies prepared by the dock-and-lock strategy for pretargeted radioimmunotherapy. Semin Nucl Med. 2010 May;40(3):190-203. doi: 10.1053/j.semnuclmed.2009.12.002.
Background: PubMed 16549819Chatal JF, Campion L, Kraeber-Bodere F, Bardet S, Vuillez JP, Charbonnel B, Rohmer V, Chang CH, Sharkey RM, Goldenberg DM, Barbet J; French Endocrine Tumor Group. Survival improvement in patients with medullary thyroid carcinoma who undergo pretargeted anti-carcinoembryonic-antigen radioimmunotherapy: a collaborative study with the French Endocrine Tumor Group. J Clin Oncol. 2006 Apr 10;24(11):1705-11. doi: 10.1200/JCO.2005.04.4917. Epub 2006 Mar 20.
Background: PubMed 16455630Kraeber-Bodere F, Rousseau C, Bodet-Milin C, Ferrer L, Faivre-Chauvet A, Campion L, Vuillez JP, Devillers A, Chang CH, Goldenberg DM, Chatal JF, Barbet J. Targeting, toxicity, and efficacy of 2-step, pretargeted radioimmunotherapy using a chimeric bispecific antibody and 131I-labeled bivalent hapten in a phase I optimization clinical trial. J Nucl Med. 2006 Feb;47(2):247-55.
Background: PubMed 14506196Kraeber-Bodere F, Faivre-Chauvet A, Ferrer L, Vuillez JP, Brard PY, Rousseau C, Resche I, Devillers A, Laffont S, Bardies M, Chang K, Sharkey RM, Goldenberg DM, Chatal JF, Barbet J. Pharmacokinetics and dosimetry studies for optimization of anti-carcinoembryonic antigen x anti-hapten bispecific antibody-mediated pretargeting of Iodine-131-labeled hapten in a phase I radioimmunotherapy trial. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):3973S-81S.
Background: PubMed 19862356Kraeber-Bodere F, Goldenberg DM, Chatal JF, Barbet J. Pretargeted radioimmunotherapy in the treatment of metastatic medullary thyroid cancer. Curr Oncol. 2009 Sep;16(5):3-8. doi: 10.3747/co.v16i5.464. No abstract available.
Background: PubMed 18311322Goldenberg DM, Chatal JF, Barbet J, Boerman O, Sharkey RM. Cancer Imaging and Therapy with Bispecific Antibody Pretargeting. Update Cancer Ther. 2007 Mar;2(1):19-31. doi: 10.1016/j.uct.2007.04.003.
Background: PubMed 16380412Goldenberg DM, Sharkey RM, Paganelli G, Barbet J, Chatal JF. Antibody pretargeting advances cancer radioimmunodetection and radioimmunotherapy. J Clin Oncol. 2006 Feb 10;24(5):823-34. doi: 10.1200/JCO.2005.03.8471. Epub 2005 Dec 27.

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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.

Robert Sharkey, PhD principal investigator

Garden State Cancer Center/Center for Molecular Medicine and Immunology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TF2/IMP288 in people with Metastatic Colorectal Cancer, run by Gilead Sciences at 1 site 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 11 inclusion and 15 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 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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?

Determine the number of adverse events (time frame: Safety will be measured routinely during the 3 weeks 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?

On the ClinicalTrials.gov record for NCT01273402, which also lists 8 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 16 Aug 2021.