HER2 Negative Breast Carcinoma Expressing CEAPhase 1/2iTEPseinNCT01730612
ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA
A Phase 1/2 study testing TF2 - 68 Ga-IMP-288: in people with HER2 Negative Breast Carcinoma Expressing CEA, run by Nantes University Hospital at 2 sites in France.
Trial summary
Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68 Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2 Negative Breast Carcinoma Expressing CEA
- What is being tested?
- TF2 - 68 Ga-IMP-288:
- How many people
- 23 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2012to May 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast carcinoma, HER2 + (Dako) and HER2 + (fish) metastatic at least after treatment with current consensus
- ≥ 18 years
- Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective contraception continuously for 3 months.
- Karnofsky ≥ 70 or ECOG 0-1
- •• ACE of the tumor by immunohistochemistry or positive plasma CEA ≥ 10 ng / mL
- At least one measurable lesion on CT
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- creatinine < 2.5
- Informed consent signed
- Social insurance
Who cannot join
- Pregnancy or breastfeeding
- Serious illness or co-morbidity risk assessed
- History of cancer within 5 years except skin cancer other than melanoma or carcinoma in situ of the cervix
- Presence of anti-antibodies in patients who have previously received antibodies
- Known hypersensitivity to antibodies or proteins
- intellectual disability to sign the informed consent
- Not controlled diabetes
- Persons protected by law
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospital
Nantes, 44093
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
About this study
Official title: Pilot Study for Optimization of Immuno-PET Pretargeted With Anti-CEA Bispecific Antibody X Anti-HSG TF2 and the Peptide IMP-288 Radiolabeled With Gallium-68 -Pharmacokinetic and Imaging for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA
Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68 Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast carcinoma.
Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the development of immunization against TF2 or complex TF2-IMP-288;
Read the detailed description
- 4 or 5 cohorts of 3 patients receiving different doses of TF2 IMP-288 with different interval time. A last cohort (4 or 5 ): maximum of 21 additional patients with the optimal schedule.
Cohort I: TF2 120 nmol / 6 nmol IMP-288 / 24 hours
Cohort II: based on the results of the cohort I :
- Good signal of the tumor but high background: increased interval time, 120 nmol TF2 / 6 nmol of IMP-288 / 30 hours
- Low signal of the tumor: reduction of the interval time, 120 nmol TF2 / 6 nmol IMP-288 / 18 hours
- Good signal of the tumor and good background signal : dose reduction, 60 nmol TF2 / 3nmol IMP- 288 / 24 hours Cohort III: based on results of cohort II:
- Good signal of the tumor : dose reduction, 120 nmol TF2 / 3 nmol IMP-288 / 30 h Cohort IV : based on results of cohort III Cohort V : Based on results of cohort IV
- A last Cohort (VI) : 19 patients with the optimal schedule of injection : 120 nmol TF2 / 3 nmol IMP-288 / 30 h or 120 nmol TF2 / 6 nmol IMP-288 / 30 h
- In the four weeks prior to the immuno-PET:
- Clinical examination,
- CEA and CA15-3,
- thoraco abdominal pelvic scan, bone scan, FDG-PET,
- immunohistochemistry ACE on the tumor if possible,
- Anti-Antibodies if the patient has already received MAb,
- pregnancy test within 2 days prior to immuno-PET,
- (creatinine > 2.5 normal) D0: Injection of TF2 D1 to D4: injection of 68 Ga-IMP-288 (depending of the cohort) D0 to D4 : pharmacokinetics, imaging Evaluation at 1 month of Immuno-PET:
- Assessment of the clinical oncologist and
- histological biopsy and / or surgery performed according to the results of imaging and assessment of the potential clinical impact Evaluation at 3 and 6 months of immuno-PET: based on the results of immuno-PET, evaluation and therapeutic decision of the oncologist,
- Imaging (ultrasound, bone scintigraphy, CT or PET FDG),
- markers
- Anti-Antibody Search
- For patient with a cancer treatment a new immuno-PET can be proposed
- Being tested
- TF2 - 68 Ga-IMP-288:
- Keywords
- ImmunoTEP, HER2 negative, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF2 - 68 Ga-IMP-288:Drug
Also called TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG), 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68
ImmunoTEP
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288
Pk blood after injections of TF2 and 68 Ga-IMP-288 and PET imaging semi-quantification with 60 to 120 minutes after injection of 68 Ga-IMP-288
Measured: One week
Secondary outcomes (2)
Sensibility, tolerance
sensitivity of the immuno-PET and compare its performance to standard imaging methods, pathological data if available data or imaging follow-up of at least 6 months by RECIST and EORTC
Measured: 6 months after immunoTEP
To study the contribution of immnoTEP to assess early response to treatment, compare its performance to standard imaging methods
6 weeks after initiation of treatment of metastases (after the first iTEP), a second _iTEP with a therapeutic evaluation will be carried out. The examination requirements are identical to those of the first immunoTEP.
this second iITEP will be evaluated in regard of imaging assessment performed routinely (TAP scanner, FDG-PET, CA15-3 and CEA)
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Negative Breast Carcinoma Expressing CEAStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- francoise Bodere, PhD, MD, Principal investigator, Nantes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730612
- Sponsor's protocol ID
- BRD/10/04-O
- Acronym
- iTEPsein
- Status last verified
- May 2017
- First submitted
- 12 Nov 2012
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Optimization of Immuno-PET Pretargeted With Anti-CEA Bispecific Antibody X Anti-HSG TF2 and the Peptide IMP-288 Radiolabeled With Gallium-68 -Pharmacokinetic and Imaging for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA
- ClinicalTrials.gov ID
- NCT01730612
- Acronym / sponsor ID
- iTEPsein / BRD/10/04-O
- Keywords
- ImmunoTEP, HER2 negative, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Gilead Sciences
- Study start
- Dec 2012
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 21 Nov 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.
Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68 Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast carcinoma.
Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the development of immunization against TF2 or complex TF2-IMP-288;
Detailed description
- 4 or 5 cohorts of 3 patients receiving different doses of TF2 IMP-288 with different interval time. A last cohort (4 or 5 ): maximum of 21 additional patients with the optimal schedule.
Cohort I: TF2 120 nmol / 6 nmol IMP-288 / 24 hours
Cohort II: based on the results of the cohort I :
- Good signal of the tumor but high background: increased interval time, 120 nmol TF2 / 6 nmol of IMP-288 / 30 hours
- Low signal of the tumor: reduction of the interval time, 120 nmol TF2 / 6 nmol IMP-288 / 18 hours
- Good signal of the tumor and good background signal : dose reduction, 60 nmol TF2 / 3nmol IMP- 288 / 24 hours Cohort III: based on results of cohort II:
- Good signal of the tumor : dose reduction, 120 nmol TF2 / 3 nmol IMP-288 / 30 h Cohort IV : based on results of cohort III Cohort V : Based on results of cohort IV
- A last Cohort (VI) : 19 patients with the optimal schedule of injection : 120 nmol TF2 / 3 nmol IMP-288 / 30 h or 120 nmol TF2 / 6 nmol IMP-288 / 30 h
- In the four weeks prior to the immuno-PET:
- Clinical examination,
- CEA and CA15-3,
- thoraco abdominal pelvic scan, bone scan, FDG-PET,
- immunohistochemistry ACE on the tumor if possible,
- Anti-Antibodies if the patient has already received MAb,
- pregnancy test within 2 days prior to immuno-PET,
- (creatinine > 2.5 normal) D0: Injection of TF2 D1 to D4: injection of 68 Ga-IMP-288 (depending of the cohort) D0 to D4 : pharmacokinetics, imaging Evaluation at 1 month of Immuno-PET:
- Assessment of the clinical oncologist and
- histological biopsy and / or surgery performed according to the results of imaging and assessment of the potential clinical impact Evaluation at 3 and 6 months of immuno-PET: based on the results of immuno-PET, evaluation and therapeutic decision of the oncologist,
- Imaging (ultrasound, bone scintigraphy, CT or PET FDG),
- markers
- Anti-Antibody Search
- For patient with a cancer treatment a new immuno-PET can be proposed
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Breast carcinoma, HER2 + (Dako) and HER2 + (fish) metastatic at least after treatment with current consensus
- ≥ 18 years
- Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective contraception continuously for 3 months.
- Karnofsky ≥ 70 or ECOG 0-1
- •• ACE of the tumor by immunohistochemistry or positive plasma CEA ≥ 10 ng / mL
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
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 - 68 Ga-IMP-288:Also: TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG), 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68ImmunoTEP | Drug | – |
Primary outcome
evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288
Time frame: One week
Pk blood after injections of TF2 and 68 Ga-IMP-288 and PET imaging semi-quantification with 60 to 120 minutes after injection of 68 Ga-IMP-288
2 secondary outcomes
Sensibility, tolerance
Time frame: 6 months after immunoTEP
To study the contribution of immnoTEP to assess early response to treatment, compare its performance to standard imaging methods
Time frame: month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
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.
francoise Bodere, PhD, MD principal investigator
Nantes Hospital
2 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 TF2 - 68 Ga-IMP-288: in people with HER2 Negative Breast Carcinoma Expressing CEA, run by Nantes University Hospital at 2 sites in France.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288 (time frame: One week). 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 27 Jul 2018.