A phase I study assessing the safety and performance of VB5-845D-800CW, an anti-Epcam fluorescent agent, for the intraoperative detection of gastrointestinal cancer

Completed

• Conditions: esophageal/gastric- or colorectal cancer; 10017990

• Registration Number: NL-OMON48830
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

Part A (healthy volunteers)
A maximum of sixteen (16) healthy volunteers will take part in this study.
Inclusion criteria
1) The subject is 18-65 years old at screening.
2) The subject is able and willing to comply with study procedures, and signed
and dated informed consent is obtained before any study-related procedure is
performed.
3) Female subjects need to be surgically sterile, post-menopausal or
pre-menopausal with a negative urine pregnancy test at screening and just
before administration of VB5-845D-800CW. Pre-menopausal female subjects have to
agree to use an effective method of contraception for 90 days after
administration. Male subjects have to agree to use an effective method of
contraception for 90 days after administration.
4) The subject has a normal or clinically acceptable medical history, physical
examination, and vital signs findings at screening.
5) The subject*s screening ECG and clinical laboratory test results are within
normal limits, or if any are outside of normal limits they are considered to be
clinically insignificant.
6) The subject has negative screening test results for hepatitis B, hepatitis
C, and human immunodeficiency virus.
7) The subject has negative test results for drug and alcohol screening.
8) Absence of any psychological, familial, sociological or geographical
condition potentially hampering compliance with the study protocol and
follow-up schedule; those conditions should be discussed with the patient
before registration in the trial.

Part B (patients)
The study will be performed in maximum 18 patients. At each dose level 6
patients will be studied. An additional 6 patients will be included in the
cohort with the most optimum dose level.
Inclusion criteria
1) Patients > 18 years;
2) Patients capable and willing to give informed consent before study specific
procedures;
3) Patients with suspected esophageal/gastric- or colorectal cancer, planned
for an open or laparoscopic esophageal/gastric resection or colorectal
resection respectively or transanal colorectal resection;
4) Normal and clinically acceptable medical history, medical physical
examination and vital signs at screening;
5) The subject*s clinical laboratory tests are within normal limits, or if any
are outside of normal limits they are considered to be clinically insignificant;
6) Absence of any physiological, familial, sociological or geographical
condition potentially hampering compliance with the study protocol and
follow-up schedule; those conditions should be discussed with the patient
before registration in the trial.

Exclusion Criteria

Part A (healthy volunteers)
A maximum of sixteen (16) healthy volunteers will take part in this study. ,
Exclusion criteria
1) Female subjects that are lactating or pregnant.
2) Unacceptable known diagnoses or diseases at baseline, e.g., known
cardiovascular or pulmonary disease, renal or liver dysfunction, ECG or
laboratory abnormalities, etc.
3) Use of prescription drugs, with the exception of contraceptive drugs.
4) Participation in a clinical trial within 90 days of screening or more than 4
times in the previous year.
5) History of significant allergies or anaphylactic reactions.

Part B (patients)
The study will be performed in maximum 18 patients. At each dose level 6
patients will be studied. An additional 6 patients will be included in the
cohort with the most optimum dose level.
Exclusion criteria
Patients will be excluded if any of the criteria below apply:
1) History of a clinically significant allergy or anaphylactic reactions;
2) Patients pregnant or breastfeeding;
3) Any condition that the investigator considers to be potentially jeopardizing
the patients well-being or the study objectives

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and tolerability endpoints<br /><br>- Treatment-emergent (serious) adverse events ((S)AEs).<br /><br>- Concomitant medication<br /><br>- Clinical laboratory tests<br /><br>o Haematology<br /><br>o Chemistry<br /><br>o Coagulation<br /><br>o Urinalysis<br /><br>- Vital signs<br /><br>o Pulse Rate (bpm)<br /><br>o Systolic blood pressure (mmHg)<br /><br>o Diastolic blood pressure (mmHg)<br /><br>o Body temperature<br /><br>o Peripheral oxygen saturation<br /><br>o Respiratory rate<br /><br>- Clinical examination, including assessment of injection site<br /><br>- ECG<br /><br>o Heart Rate (HR) (bpm), PR, QRS, QT, QTC<br /><br><br /><br></p><br>