Healthy VolunteersPhase 1CAM-VHH1NCT02683083
Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients
A Phase 1 study testing [131I]-SGMIB Anti-HER2 VHH1 in people with Healthy Volunteers and Breast Cancer, run by Precirix at 1 site in Belgium.
Trial summary
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Breast Cancer
- What is being tested?
- [131I]-SGMIB Anti-HER2 VHH1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2016to 5 Feb 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will only be included in the study if they meet all of the following criteria:
- Subjects who have given informed consent
- Subjects that agree not to drink alcoholic beverages or use any drugs during the study
- Subject with blood parameters within normal ranges
- Age: at least 18 years old
- Patients will only be included in the study if they meet all of the following criteria:
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- Patients who have given informed consent
- Patients that agree not to drink alcoholic beverages or use any drugs during the study
- Age: at least 18 years old
- Patients with local, locally advanced or metastatic HER2+ breast carcinoma as diagnosed on biopsied tissue by immunohistochemistry or fluorescence in situ hybridization (FISH).
Who cannot join
- Patients will not be included in the study if one of the following criteria applies:
- Pregnant patients
- Breast feeding patients
- Patients with occupational exposure to ionizing irradiation
- Patients with previous thyroid disorders
- Patients that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.
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- Patients with absolute contra-indications for thyroid blockage with potassium iodide.
- Patients with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.
- Patients with abnormal kidney function: < 50 ml/min/1,73 m2
- Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
- Patients with any serious active infection
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
- Patients who cannot communicate reliably with the investigator
- Patients who are unlikely to cooperate with the requirements of the study
- Patients at increased risk of death from a pre-existing concurrent illness
- Patients who participated already in this study
- Patients who participated in a previous trial with Anti-HER2 VHH1
- Subjects will not be included in the study if one of the following criteria applies:
- Pregnant subjects
- Breast feeding subjects
- Subjects with occupational exposure to ionizing irradiation
- Subjects with clinical significant disease or on concomitant therapy (except contraception)
- Subjects with previous thyroid disorders
- Subjects that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.
- Subjects with absolute contra-indications for thyroid blockage with potassium iodide.
- Subjects with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.
- Subjects with abnormal kidney function: < 50 ml/min/1,73 m2
- Subjects with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
- Subjects with any serious active infection
- Subjects who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test radiopharmaceutical
- Subjects who cannot communicate reliably with the investigator
- Subjects who are unlikely to cooperate with the requirements of the study
- Subjects at increased risk of death from a pre-existing concurrent illness
- Subjects who participated already in this study
- Subjects who participated in a previous trial with Anti-HER2 VHH1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients: CAM-VHH1 Study
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.
Secondary purpose of the clinical study is to evaluate the tumor uptake of [131I]-SGMIB Anti-HER2 VHH1 in patients with HER2+ breast cancer.
- Conditions
- Healthy Volunteers, Breast Cancer
- Being tested
- [131I]-SGMIB Anti-HER2 VHH1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[131I]-SGMIB Anti-HER2 VHH1Biological
| Study group | Role | What they receive |
|---|---|---|
| [131I]-SGMIB Anti-HER2 VHH1 | Experimental | Not described Receives: Biological: [131I]-SGMIB Anti-HER2 VHH1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Measured: 1 day
Secondary outcomes (1)
The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan
Cancer lesions above 3 cm will be visually interpreted by an experienced nuclear medicine physician. Lesions will be scored positive if CAM-H2 uptake in the lesion is higher than surrounding background.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startOct 2016
- Primary completion5 Feb 2018
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precirix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683083
- Sponsor's protocol ID
- CAM-VHH1
- Other IDs
- 2015-004840-21, 2015
- Acronym
- CAM-VHH1
- Status last verified
- Jul 2019
- First submitted
- 9 Feb 2016
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients: CAM-VHH1 Study
- ClinicalTrials.gov ID
- NCT02683083
- Acronym / sponsor ID
- CAM-VHH1 / CAM-VHH1
- Conditions
- Healthy Volunteers, Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- PrecirixIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Posted 18 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.
Secondary purpose of the clinical study is to evaluate the tumor uptake of [131I]-SGMIB Anti-HER2 VHH1 in patients with HER2+ breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [131I]-SGMIB Anti-HER2 VHH1 | Experimental | Biological: [131I]-SGMIB Anti-HER2 VHH1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who have given informed consent
- Subjects that agree not to drink alcoholic beverages or use any drugs during the study
- Subject with blood parameters within normal ranges
- Age: at least 18 years old
- Patients who have given informed consent
Key exclusion criteria (35 listed)
- Pregnant patients
- Breast feeding patients
- Patients with occupational exposure to ionizing irradiation
- Patients with previous thyroid disorders
- Patients that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.
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 |
|---|---|---|
| [131I]-SGMIB Anti-HER2 VHH1 | Biological | [131I]-SGMIB Anti-HER2 VHH1 |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: 1 day
1 secondary outcome
The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 [131I]-SGMIB Anti-HER2 VHH1 in people with Healthy Volunteers and Breast Cancer, run by Precirix at 1 site in Belgium.
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 10 inclusion and 35 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 7 Aug 2019. 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 Belgium. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (time frame: 1 day). 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 7 Aug 2019.