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Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas

Primary Purpose

Colon Cancer, Rectum Cancer, Pancreas Cancer

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

SGM-101

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring Fluorescence, Surgery, Cancer, SGM-101, Near Infrared, Immunophotodetection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged over 18 years old;
Patient should be scheduled and eligible for surgery because of a clinical diagnosis of cancer of the colon, rectum or cancer of the pancreas;
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
Patients should be capable and willing to give informed consent before study specific procedures.

Exclusion Criteria:

Anticancer therapy (e.g. chemotherapy, radiotherapy (except for routine pre-operative radiotherapy for colorectal cancer), targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion;
History of a clinically significant allergy;
Circulating plasma concentration CEA ≥ 300 ng / ml;
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;
Patients pregnant or breastfeeding (pregnancy should be ruled out by an assay of βhCG plasma within 4±1 weeks prior to administration of the conjugate), lack of effective contraception in male or female patients with reproductive potential;
Laboratory abnormalities defined as:

Colorectal 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 Upper Limit Normal (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);
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' wellbeing or the study objectives.

Sites / Locations

Catharina Ziekenhuis Eindhoven
Leiden University Medical Center
Erasmus Medical Center Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SGM-101

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with treatment-related adverse events

An Adverse Event (AE) is any untoward medical occurrence in a subject who is participating in a clinical study performed. The adverse event does not necessarily have to follow the administration of a study drug, or to have a causal relationship with the study drug. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory or vital sign finding), symptom, or disease temporally associated with the study participation, whether or not it is related to the study drug.

Secondary Outcome Measures

Tumor-to-background ratio (TBR) for fluorescence

Serum SGM-101 concentrations

Individual serum SGM-101 concentrations will be plotted versus time per individual using both a linear and log y-axis. Additionally, concentration versus time curves will be plotted per treatment group as a spaghetti plot. Concentrations will be summarized by treatment group.

Full Information

NCT ID

NCT02973672

First Posted

November 16, 2016

Last Updated

July 16, 2019

Sponsor

Surgimab

Collaborators

Centre for Human Drug Research, Netherlands, Leiden University Medical Center, Erasmus Medical Center, Catharina Ziekenhuis Eindhoven

1. Study Identification

Unique Protocol Identification Number

NCT02973672

Brief Title

Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas

Official Title

A Phase I Study Assessing the Safety and Performance of SGM-101, a Fluorochrome-labeled Anti-carcino-embryonic Antigen Monoclonal Antibody for the Detection of Neoplastic Lesions in Patients With Colorectal Cancer or Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

April 15, 2019 (Actual)

Study Completion Date

May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Surgimab

Collaborators

Centre for Human Drug Research, Netherlands, Leiden University Medical Center, Erasmus Medical Center, Catharina Ziekenhuis Eindhoven

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the visualization of CEA-expressing cancers during surgery. SGM-101 is injected 2 to 4 days before surgery and visualized using an optimized camera system.

Detailed Description

Surgery is the most important therapy for patients with cancer of the colon, rectum or pancreas. Complete resection, which is a crucial factor in the prognosis of a patient, is challenging as surgeons have to rely on visual appearance and palpation to discriminate between tumor and normal tissue. Carcinoembryonic antigen (CEA) is a tumor-specific marker that is highly expressed in a number of tumors of epithelial origin (such as colorectal carcinoma and pancreas carcinoma) while it is minimally expressed in normal adult tissues. The compound that will be studied in this research project is SGM-101, a CEA-specific chimeric antibody conjugated with a near-infrared (NIR) emitting moiety. The hypothesis is that, following preoperative iv administration of SGM-101 in patients with carcinoma of the colon, rectum or pancreas, SGM-101 will bind to CEA expressing cancer cells and these cells can then be visualized with a NIR fluorescence imaging system, thereby increasing the chance of radical resection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer, Rectum Cancer, Pancreas Cancer, Metastatic Colorectal Cancer, Recurrent Colorectal Carcinoma

Keywords

Fluorescence, Surgery, Cancer, SGM-101, Near Infrared, Immunophotodetection

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SGM-101

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SGM-101

Other Intervention Name(s)

SGM 101, SGM101

Intervention Description

4 days before surgery, SGM-101 will be administered to the patient by intravenous injections.

Primary Outcome Measure Information:

Title

Number of patients with treatment-related adverse events

Description

Time Frame

up to 10 days after the surgery

Secondary Outcome Measure Information:

Title

Tumor-to-background ratio (TBR) for fluorescence

Time Frame

day 4

Title

Serum SGM-101 concentrations

Description

Time Frame

up to 1 month after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged over 18 years old; Patient should be scheduled and eligible for surgery because of a clinical diagnosis of cancer of the colon, rectum or cancer of the pancreas; 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 Patients should be capable and willing to give informed consent before study specific procedures. Exclusion Criteria: Anticancer therapy (e.g. chemotherapy, radiotherapy (except for routine pre-operative radiotherapy for colorectal cancer), targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion; History of a clinically significant allergy; Circulating plasma concentration CEA ≥ 300 ng / ml; 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; Patients pregnant or breastfeeding (pregnancy should be ruled out by an assay of βhCG plasma within 4±1 weeks prior to administration of the conjugate), lack of effective contraception in male or female patients with reproductive potential; Laboratory abnormalities defined as: Colorectal 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 Upper Limit Normal (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); 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' wellbeing or the study objectives.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander L Vahrmeijer, MD, PhD

Organizational Affiliation

Leiden University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Catharina Ziekenhuis Eindhoven

City

Eindhoven

Country

Netherlands

Facility Name

Leiden University Medical Center

City

Leiden

ZIP/Postal Code

2333 CL

Country

Netherlands

Facility Name

Erasmus Medical Center Cancer Institute

City

Rotterdam

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32416765

Citation

Lwin TM, Hoffman RM, Bouvet M. The future of tumour-specific fluorescence-guided surgery for pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):715-717. doi: 10.1016/S2468-1253(20)30123-0. Epub 2020 May 14. No abstract available.

Results Reference

derived

PubMed Identifier

31960953

Citation

Schaap DP, de Valk KS, Deken MM, Meijer RPJ, Burggraaf J, Vahrmeijer AL, Kusters M; SGM-101 study group. Carcinoembryonic antigen-specific, fluorescent image-guided cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for metastatic colorectal cancer. Br J Surg. 2020 Mar;107(4):334-337. doi: 10.1002/bjs.11523. Epub 2020 Jan 21.

Results Reference

derived

PubMed Identifier

29361435

Citation

Boogerd LSF, Hoogstins CES, Schaap DP, Kusters M, Handgraaf HJM, van der Valk MJM, Hilling DE, Holman FA, Peeters KCMJ, Mieog JSD, van de Velde CJH, Farina-Sarasqueta A, van Lijnschoten I, Framery B, Pelegrin A, Gutowski M, Nienhuijs SW, de Hingh IHJT, Nieuwenhuijzen GAP, Rutten HJT, Cailler F, Burggraaf J, Vahrmeijer AL. Safety and effectiveness of SGM-101, a fluorescent antibody targeting carcinoembryonic antigen, for intraoperative detection of colorectal cancer: a dose-escalation pilot study. Lancet Gastroenterol Hepatol. 2018 Mar;3(3):181-191. doi: 10.1016/S2468-1253(17)30395-3. Epub 2018 Jan 30.

Results Reference

derived

Learn more about this trial

Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas

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