Clinical Trials Register

Summary
EudraCT Number:	2018-000151-40
Sponsor's Protocol Code Number:	SGM-CLIN03
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-05-13
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2018-000151-40

A.3

Full title of the trial

Multicenter, semi-blinded, randomized, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Fluorescence for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer.

A.4.1

Sponsor's protocol code number

SGM-CLIN03

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Surgimab
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Surgimab
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Surgimab
B.5.2	Functional name of contact point	Françoise Cailler
B.5.3	Address:
B.5.3.1	Street Address	10, Parc Club du Millénaire; 1025, avenue Henri Becquerel
B.5.3.2	Town/ city	Montpellier
B.5.3.3	Post code	34000
B.5.3.4	Country	France
B.5.4	Telephone number	0033467798381
B.5.6	E-mail	fcailler@surgimab.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	fluorochrome-labeled anti-carcino-embryonic antigen
D.3.2	Product code	SGM-101
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SGM-101
D.3.9.2	Current sponsor code	SGM-101
D.3.9.3	Other descriptive name	CEA‐SPECIFIC CHIMERIC ANTIBODY CONJUGATED WITH A NIR EMITTING FLUOROCHROME
D.3.9.4	EV Substance Code	SUB196517
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients undergoing curative surgery for colorectal cancer

E.1.1.1

Medical condition in easily understood language

colorectal cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10010030
E.1.2	Term	Colorectal cancer recurrent
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10010035
E.1.2	Term	Colorectal cancer stage IV
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10010034
E.1.2	Term	Colorectal cancer stage III
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10052358
E.1.2	Term	Colorectal cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To analyze the clinical benefit resulting from the use of Fluorescence Guided Surgery (FGS) during the surgical procedure, with SGM-101 as the intraoperative imaging agent, in terms of additional cancer lesions resected.

E.2.2

Secondary objectives of the trial

1. To analyze the clinical benefit resulting from the use of Fluorescence Guided Surgery (FGS) during the surgical procedure, with SGM-101 as the intraoperative imaging agent, in terms of preservation of non-cancer tissue.
2. To analyze the false detection rate of FGS during the surgical procedure, with SGM-101 as the intraoperative imaging agent.
3. To analyze the clinical benefit resulting from the use of FGS during the surgical procedure, with SGM-101 as the intraoperative imaging agent, in terms of overall benefit.
4. Diagnostic performance of FGS: Accuracy
5. To further characterize diagnostic performance by analyzing the PPV, NPV, Sensitivity and Specificity of FGS.
6. Diagnostic performance of FGS versus fresh frozen sections.
7. To describe the TBR
8. To document the impact of SGM-101 injection on the surgical procedure
9. To evaluate tolerability/safety of SGM-101 injection
10. To evaluate short term surgical outcomes

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients aged over 18 years old;
2. Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer;
3. Female patients should not be of child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal) nor breastfeeding. Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection;
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
4. Patients should be capable and willing to give informed consent before study specific procedures.

E.4

Principal exclusion criteria

1. Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
2. Primary appendiceal cancer;
3. Laboratory abnormalities defined as:
- Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
- Total bilirubin above 2 times the ULN or;
- Serum creatinine above 1.5 times the ULN or;
- Platelet count below 100 x 109/L or;
- Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
4. 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;
5. Use of any investigational drug during 4 weeks before the Injection Day.
6. Any condition that the investigator considers it would potentially jeopardize the patient’s well-being or the study objectives such as severe anaphylactic reaction in medical history, previous allergic reaction to SGM-101 or to any excipient present in the product or known Hypersensitivity to murine proteins.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients who have at least one additional biopsy/ resection identified under NIR but not under WL that are true positives (TP).

E.5.1.1

Timepoint(s) of evaluation of this end point

Day of the surgery

E.5.2

Secondary end point(s)

1.“Conservative surgery benefit” rate: P2
Proportion of patients who have more [WL positive, NIR negative, pathology negative lesions] (NIR true negatives) than [WL negative, NIR positive, pathology negative] (NIR false positive) lesions, i.e. a net benefit in numbers of negative lesions wrongly resected.

2. False detection rate: P3
Proportion of patients who have all additional biopsies / resections under NIR that are false positives (FP).

3. Composite endpoint at the patient level: Clinical benefit (or “positive” change in surgery plan or post-surgical management of the patient resulting from the use of FGS) rate P4.
Clinical benefit will be assessed within each patient by comparing standard of care surgery without fluorescence to surgery with fluorescence and assessing if the latter allowed to remove any additional pathologically confirmed malignant lesion and/or to resect less nonmalignant tissue, and/or to adapt the post-surgical management, each patient serving as his own control.
The outcome measure will be the rate of patients with clinical benefit.

4. The accuracy rate will be used as the main endpoint to assess intraoperative imaging agent performance. The statistical analysis will consist in describing the concordance between FGS using SGM-101 as intraoperative imaging agent and the pathology results (final pathology when available or FFS if not sent to pathology) with respect to the presence of cancer using rates of true positives (TP), false positives (FP), false negatives (FN), true negatives (TN) and the accuracy rate (TP+TN). These will be computed at the patient level for both all lesions and additional lesions identified with fluorescent light only, and at lesion level.

5. •Positive Predictive value (PPV) (percentage of histologically (final pathology when available or FFS if not sent to pathology) positive lesions among fluorescent lesions),
•Negative Predictive value (NPV) (percentage of histologically (final pathology when available or FFS if not sent to pathology) negative lesions among non-fluorescent lesions),
•Sensitivity ratio (Se) (malignant results correctly identified by fluorescence),
•Specificity ratio (Sp) (non-malignant results correctly identified by fluorescence).

6. The diagnostic performance of FGS will be analyzed on the subgroup of patients with fresh frozen sections taken during surgery, to assess if FGS could replace fresh frozen sections, resulting in a potential benefit on the total duration of the surgical procedure.

7. Computation of descriptive statistics for TBR, defined as fluorescent signal of tumor tissue compared to fluorescence signal of normal tissue surrounding the tumor.

8. Assessment of the impact of SGM-101 injection on the surgical procedure (rapidity of the evaluation, easiness of detection of additional nodules, duration of surgical procedure, duration of anesthesia) with the surgeon’s questionnaire

9. Routine clinical measurements such as treatment-emergent adverse events, blood pressure, heart rate, temperature, peripheral oxygen saturation, respiratory rate, skin examination, and routine laboratory assessments.

10. Assessment of adverse events related to surgery within a period of 32 days following SGM-101 injection in order to substantiate the benefit/risk assessment of the use of SGM-101 and assess a possible bias in the surgeons’ approach due to the use of fluorescence.

E.5.2.1

Timepoint(s) of evaluation of this end point

Endpoint # 1, 2, 3, 4, 5, 6, 7, 8 = Day of the surgery

Endpoint # 9 and 10: From SGM-101 injection to 28 days after surgery

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Semi Blind

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Saline injection followed by standard surgical treatment

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

United States

Italy

Netherlands

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

150

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

300

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-01-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-04-18

P. End of Trial
P.	End of Trial Status	Ongoing

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