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

NCT ID: NCT02683083

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-02-05

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.

Conditions

Healthy Volunteers; Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[131I]-SGMIB Anti-HER2 VHH1

Group Type: EXPERIMENTAL

[131I]-SGMIB Anti-HER2 VHH1

Intervention Type: BIOLOGICAL

Interventions

[131I]-SGMIB Anti-HER2 VHH1

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Precirix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Brussel

Brussels, Choose A State, Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-004840-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAM-VHH1

Identifier Type: -

Identifier Source: org_study_id