Clinical trial NCT02683083: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Breast Cancer
Lead sponsor: Precirix
Sponsor class: INDUSTRY
First posted: 2016-02-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
timeFrame: 1 day
Secondary outcomes:
measure: The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan
timeFrame: 1 day
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
state: Choose A State
Study officials:
References: