SGM-101 for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byAlex L. Vahrmeijer,, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Surgimab

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.

Eligibility Criteria

This trial is for adults with colorectal cancer who are scheduled for surgery. It's open to those with primary advanced or recurrent tumors, including peritoneal metastases. Women must be non-childbearing or agree to contraception. Excluded are individuals with certain blood abnormalities, liver and kidney issues, active infections, HIV/HBV/HCV, other recent cancers except some skin/cervical cancers.

Inclusion Criteria

I am a woman who cannot become pregnant or will use birth control around my treatment.

I am scheduled for surgery aimed at curing advanced or recurrent colorectal cancer.

Exclusion Criteria

My cancer originates from the appendix.

I have no active cancers and haven't been diagnosed with any in the past 5 years, except for treated skin cancer or cervical carcinoma.

Laboratory abnormalities defined as: Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN, Total bilirubin above 2 times the ULN, Serum creatinine above 1.5 times the ULN, Absolute neutrophils counts below 1.5 x 109/L, Platelet count below 100 x 109/L, Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males), 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, Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Participant Groups

SGM-101, a fluorescent imaging agent used during surgery for colorectal cancer is being tested against the standard white light method. The goal is to see if SGM-101 helps surgeons better identify and remove cancerous tissue.

2Treatment groups

Active Control

Group I: TreatmentActive Control1 Intervention

Patients will receive a single dose of the study drug, SGM-101, and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR.

Group II: No TreatmentActive Control1 Intervention

Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only.