Breast Cancer, Healthy Volunteers
Conditions
Brief 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. Secondary purpose of the clinical study is to evaluate the tumor uptake of \[131I\]-SGMIB Anti-HER2 VHH1 in patients with HER2+ breast cancer.
Interventions
BIOLOGICAL[131I]-SGMIB Anti-HER2 VHH1
Sponsors
Precirix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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: * 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).
Exclusion criteria
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. * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 1 day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan | 1 day | 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| [131I]-SGMIB Anti-HER2 VHH1 All subjects received one single intravenous injection of the investigational medical product (\[131I\]-SGMIB Anti-HER2 VHH1). | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | [131I]-SGMIB Anti-HER2 VHH1 |
|---|---|
| Age, Continuous | 39.78 years STANDARD_DEVIATION 18.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 4 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| [131I]-SGMIB Anti-HER2 VHH1 | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 0 Participants |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| [131I]-SGMIB Anti-HER2 VHH1 | The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan | 2 Participants |