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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683083
Recruitment Status : Completed
First Posted : February 17, 2016
Results First Posted : July 18, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Camel-IDS NV

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Breast Cancer Biological: [131I]-SGMIB Anti-HER2 VHH1 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : October 2016
Actual Primary Completion Date : February 5, 2018
Actual Study Completion Date : February 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: [131I]-SGMIB Anti-HER2 VHH1 Biological: [131I]-SGMIB Anti-HER2 VHH1



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

Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683083


Locations
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Belgium
UZ Brussel
Brussels, Choose A State, Belgium, 1090
Sponsors and Collaborators
Camel-IDS NV
  Study Documents (Full-Text)

Documents provided by Camel-IDS NV:
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Responsible Party: Camel-IDS NV
ClinicalTrials.gov Identifier: NCT02683083    
Other Study ID Numbers: CAM-VHH1
2015-004840-21 ( EudraCT Number )
First Posted: February 17, 2016    Key Record Dates
Results First Posted: July 18, 2019
Last Update Posted: August 7, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases