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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Academisch Ziekenhuis Leiden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]

Trial duration

16 Oct 2019 → ongoing

Decision date (initial)

2024-10-01

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

SurgiMab · KWF

External identifiers

EU CT number

2024-510768-21-00

EudraCT number

2019-001748-23

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Diagnosis

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.

Secondary objectives 4

1. To determine the effect of FGOS combined with SGM-101 on intra-operative decision making. The corresponding endpoint is the clinical benefit at the patient level; a “positive” change in surgical plan (e.g. more/less extensive resection or more adequate application of IORT) or post-surgical management, resulting from the use of SGM-101. The predetermined surgical plan (based on radiology results) will be compared to the performed surgery. Moreover, standard of care surgery will be compared to FGOS and assessing if the latter allowed to remove any additional histopathologically confirmed malignant lesions (extra locoregional lymph nodes and resection margins) and/or to resect less non-malignant tissue, each patient serving as its own control.
2. To determine the performance of SGM-101 in the intra-operative detection of rectal cancer. The corresponding endpoint will be the tumor-to-background ratio; defined as fluorescent signal of tumor tissue compared to fluorescence signal of normal tissue surrounding the tumor. In addition, the concordance between fluorescent signal and histopathologic results will be defined.
3. To compare intra-operative fluorescence imaging with SGM-101 and histopathology. The corresponding endpoints will be the rate of false negatives, false positives, true negatives and true positives.
4. To determine the changes in surgical planning due to FGOS combined with SGM-101 on mortality and postoperative complications caused by the surgical procedure. The corresponding endpoints are 30-day mortality and 30-day complication rates in order to substantiate the benefit/risk assessment of the use of SGM-101.

Conditions and MedDRA coding

Rectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients aged over 18 years old
2. 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.
3. 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)
4. Patients should be capable and willing to give signed informed consent before study specific procedures.

Exclusion criteria 7

1. 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.
2. Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery).
3. Patient with a history of a clinically significant allergy.
4. Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential.
5. 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.
6. Any condition that the investigator considers to be potentially jeopardizing the patients’ well-being or the study objectives.
7. Previous administration of SGM-101.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the rate of patients with R0 resections. This endpoint is based on the primary objective of clinical benefit of FGOS combined with SGM-101 as the intraoperative imaging agent.

Secondary endpoints 6

1. Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology.
2. For every removed specimen: rate of false negatives, false positives, true negatives and true positives concerning fluorescence, with histopathology as the gold standard.
3. Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue.
4. Modification of operative plan due to imaging (e.g. more/less extensive resection or adjustment of IORT) and change in postoperative treatment will be recorded.
5. 30-day mortality and 30-day complication rates.
6. 2-year overall survival, 2-year disease free survival and 2-year local recurrence free survival.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Academisch Ziekenhuis Leiden

Sponsor organisation

Academisch Ziekenhuis Leiden

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Clinical Research Center, dept. of Surgery

Public contact point

Organisation

Academisch Ziekenhuis Leiden

Contact name

Clinical Research Center, dept. of Surgery

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications