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

Breast Cancer Clinical Trial

— CAM-VHH1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683083
• Other study ID #: CAM-VHH1
• Secondary ID: 2015-004840-21
• Status: Completed
• Phase: Phase 1
• Start date: October 2016
• Est. completion date: February 5, 2018

Study information

• Verified date: July 2019
• Source: Camel-IDS NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Secondary purpose of the clinical study is to evaluate the tumor uptake of [131I]-SGMIB Anti-HER2 VHH1 in patients with HER2+ breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 5, 2018
• Est. primary completion date: February 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Healthy Volunteers

Intervention

Biological:
• [131I]-SGMIB Anti-HER2 VHH1

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels	Choose A State

Sponsors (1)

Lead Sponsor	Collaborator
Camel-IDS NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0		1 day
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.	1 day