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

NCT02683083 | Completed Phase 1 Results DMC

• 2 other identifiers: CAM-VHH12015-004840-21
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  1 day

Secondary Outcomes (1)

• The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan

  1 day

Study Arms (1)

[131I]-SGMIB Anti-HER2 VHH1

EXPERIMENTAL

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

Interventions

[131I]-SGMIB Anti-HER2 VHH1 BIOLOGICAL

[131I]-SGMIB Anti-HER2 VHH1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Precirix: lead

Study Sites (1)

UZ Brussel

Brussels, Choose A State, 1090, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Tony Lahoutte
• Organization: Camel-IDS

tony.lahoutte@camel-ids.com

0032 24799360

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 17, 2016
• Study Start: October 1, 2016
• Primary Completion: February 5, 2018
• Study Completion: February 5, 2018
• Last Updated: August 7, 2019
• Results First Posted: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)