Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer (MACROSWITCH)

Our goal is to create novel CD47-SIRPα inhibitors using small molecules to reverse TAM-mediated immune suppression and restore anti-tumor immunity in CRCs. Our program uses structure-based drug design to create selective and potent small molecule inhibitors of SIRPα-CD47 to target the tumor microenvironment with greater efficacy and lower toxicity than CD47-targeting antibodies. .

In order to study the activity of CD47-SIRPα inhibitors on the immune microenvironment of tumors, we propose to use organoids derived from biopsies of patients with colon cancer. Tumoroids preserve the patient's tumor stroma (including myeloid cells) and provide an accurate in vitro model of complex tumor immune interaction for the evaluation of immunotherapies.

Study Overview

• Status: Recruiting
• Conditions: Cancer of the Colon
• Intervention / Treatment: Procedure: BLOOD AND TUMOR

• Study Type: Observational
• Enrollment (Estimated): 115

Contacts and Locations

• Study Contact: Name: Dominique Genre, MD; Phone Number: +33491223778; Email: drci.up@ipc.unicancer.fr

Study Locations

• France
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli Calmettes
    • Contact: GENRE Dominique
    • Contact: Phone Number: 33 (0)4 91 22 37 78; Email: drci.up@ipc.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population studied concerns patients over the age of 18, suffering from colon cancer, undergoing immediate surgery or after chemotherapy.

Description

Inclusion Criteria:

• Patient over 18 years old
• Patient who has signed a consent to participate;
• Patient with metastatic or non-metastatic colon cancer, or recurrence of colon cancer for whom excision surgery has been proposed;
• Patient affiliated to a social security scheme, or beneficiary of such a scheme

Exclusion Criteria:

• Patient who had emergency colon cancer surgery
• Person in an emergency situation or unable to express their consent.
• Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
• Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of patient derived organoids (minimum n=30) resembling the primary tissue sample	the capacity to establish patient-derived organoids from tumor and adjacent normal tissue will be evaluated using a histology score evaluating and comparing primary and organoid sample characteristics.	18 months from study launch

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of a validated cryobank of patient derived organoids (minimum n=30)	the capacity to establish a cryobank of patient-derived organoids from tumor and adjacent normal tissue will be evaluated using a growth score evaluating and comparing organoid sample characteristics pre- and post-cryopreservation and amplification through 4 passages.	18 months from study launch
Generate a T cell biobank by FACS isolating T cells using the CD3 surface marker directed against the human form		48 month
To assess the effect of immunotherapy on the antitumor activity of autologous T cells from peripheral blood samples using tumor viability measurements (cell titer glo, FACS)		48 month

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Cécile de CHAISEMARTIN, MD, Paoli Calmettes Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Estimated): January 9, 2025
• Study Completion (Estimated): January 9, 2027

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: MACROSWITCH-IPC 2021-083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No