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)

July 24, 2019 updated by: Precirix

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Choose A State
      • Brussels, Choose A State, Belgium, 1090
        • UZ Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [131I]-SGMIB Anti-HER2 VHH1
Biological: [131I]-SGMIB Anti-HER2 VHH1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precirix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

February 5, 2018

Study Completion (Actual)

February 5, 2018

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAM-VHH1
  • 2015-004840-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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