A Phase I Study Assessing the Safety and Performance of SGM-101, a Fluorochrome-Labeled Anti-Carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Neoplastic Lesions in Patients with Cancer of the Colorectum or Pancreas

Completed

• Conditions: cancer of colon; colorectal and pancreatic carcinoma; rectum and pancreas; 10017991; 10017998

• Registration Number: NL-OMON47359
• Lead Sponsor: Surgimab

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 85

Inclusion Criteria

1. Patients aged over 18 years old;
2. Patient should be scheduled and eligible for surgery because of a clinical diagnosis of cancer of the colon rectum or cancer of the pancreas;
3. Both pancreatic and colorectal cancer patients: Circulating plasma CEA * the upper limit of normal range (eg * 3.0 ng / ml);
Patient suffering from recurrences and metastasis of colorectal cancer: Rising circulating plasma CEA);
4. Patients should be capable and willing to give informed consent before study specific procedures.

Exclusion Criteria

1. Anticancer therapy (e.g. chemotherapy, radiotherapy (except for routine pre-operative radiotherapy in rectal cancer), targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion;
2. History of a clinically significant allergy;
3. Circulating plasma concentration CEA * 300 ng / ml;
4. Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
5. Patients pregnant or breastfeeding (pregnancy should be ruled out by an assay of *hCG plasma within two weeks prior to administration of the conjugate), lack of effective contraception in male or female patients with reproductive potential;
6. Laboratory abnormalities defined as:
Rectal cancer patients only:
* Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
* Total bilirubin above 2 times the ULN or;
Both pancreatic and colorectal cancer patients:
* Serum creatinine above 1.5 times the ULN or;
* Absolute neutrophils counts below 1.5 x 109/L or;
* Platelet count below 100 x 109/L or;
* Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males).
7. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
8. Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and tolerability (primary endpoint)<br /><br>Tolerability/safety will be assessed using routine clinical measures such<br /><br>treatment-emergent adverse events, blood pressure, heart rate, temperature,<br /><br>peripheral oxygen saturation, respiratory rate, skin examination, and routine<br /><br>laboratory assessments. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Performance (secondary endpoint)<br /><br>Performance of SGM-101 will be defined by tumor to background ratio (TBR) for<br /><br>fluorescence, and the concordance between the intraoperative fluorescence<br /><br>assessment of suspected lesions and their histopathology. In addition after<br /><br>resection, margins will be assessed using fluorescence imaging to detect<br /><br>potential irradical resection.<br /><br><br /><br>Pharmacokinetics (secondary endpoint)<br /><br>Cmax, T*, AUC, Tmax, Clearance. In addition, the relationship between<br /><br>pharmacokinetics and performance will be assessed.</p><br>