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SGM-LARRC: Multicenter, open-label, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for locally advanced or recurrent rectal cancerpatients undergoing curative surgery.
EU CTIS ID: 2024-510768-21-00
What this study is testing
The primary objective is based on the clinical benefit of FGOS combined with SGM-101 as the intraoperative imaging agent. The corresponding endpoint is the rate of patients with R0 resections.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged over 18 years old
- All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
- Patients should be scheduled and eligible for surgery because of a clinical diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or recurrent rectal cancer. (UICC. TNM classification of diseases for oncology. 3rd ed. Geneva: World Health Organization; 2000)
- Patients should be capable and willing to give signed informed consent before study specific procedures.
You likely can't join if
- Other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
- Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery).
- Patient with a history of a clinically significant allergy.
- Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential.
- Laboratory abnormalities defined as: a. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or; b. Total bilirubin above 2 times the ULN or; c. Serum creatinine above 1.5 times the ULN or; d. Platelet count below 100 x 109/L or; e. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males); f. 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 patients’ well-being or the study objectives.
See the full eligibility criteria
- Patients aged over 18 years old
- All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
- Patients should be scheduled and eligible for surgery because of a clinical diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or recurrent rectal cancer. (UICC. TNM classification of diseases for oncology. 3rd ed. Geneva: World Health Organization; 2000)
- Patients should be capable and willing to give signed informed consent before study specific procedures.
- Other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
- Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery).
- Patient with a history of a clinically significant allergy.
- Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential.
- Laboratory abnormalities defined as: a. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or; b. Total bilirubin above 2 times the ULN or; c. Serum creatinine above 1.5 times the ULN or; d. Platelet count below 100 x 109/L or; e. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males); f. 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 patients’ well-being or the study objectives.
- Previous administration of SGM-101.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.