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

• Part A (healthy volunteers)

A maximum of sixteen (16) healthy volunteers will take part in this study.



Inclusion criteria

- The subject is 18-65 years old at screening.

- 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.

- 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.

- The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening.

- 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.

- The subject has negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus.

- The subject has negative test results for drug and alcohol screening.

- 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, 3 patients for each indication. An additional 3 patients will be included for each indication in the cohort with the most optimum dose level.



Inclusion criteria

- Patients > 18 years;

- Patients capable and willing to give informed consent before study specific procedures;

- Patients with suspected esophageal/gastric- or rectosigmoid cancer, planned for an open or laparoscopic esophageal/gastric resection or sigmoid/low anterior resection respectively;

- Normal and clinically acceptable medical history, medical physical examination and vital signs at screening;

- 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;

- 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.

• Part A (healthy volunteers)

A maximum of sixteen (16) healthy volunteers will take part in this study.



Exclusion criteria

- Female subjects that are lactating or pregnant.

- Unacceptable known diagnoses or diseases at baseline, e.g., known cardiovascular or pulmonary disease, renal or liver dysfunction, ECG or laboratory abnormalities, etc.

- Use of prescription drugs, with the exception of contraceptive drugs.

- Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.

- 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, 3 patients for each indication. An additional 3 patients will be included for each indication in the cohort with the most optimum dose level.



Exclusion criteria

Patients will be excluded if any of the criteria below apply:

- History of a clinically significant allergy or anaphylactic reactions;

- Patients pregnant or breastfeeding;

- Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives