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

NCT05955196 | Recruiting

• 1 other identifier: MACROSWITCH-IPC 2021-083
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of the Colon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Establishment of a validated cryobank of patient derived organoids (minimum n=30)

  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

Interventions

BLOOD AND TUMOR PROCEDURE

sampling of 24 ml of peripheral blood and samples of colon cancers with healthy tissue in parallel on the surgery piece

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood; samples of colon cancers with healthy tissue in parallel on the surgical specimen

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Tumor Burden

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Body Weights and Measures; Anthropometry; Investigative Techniques

Study Officials

• Cécile de CHAISEMARTIN, MD

  Paoli Calmettes Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique GENRE, MD

CONTACT

+33491223778; drci.up@ipc.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: July 21, 2023
• Study Start: January 9, 2023
• Primary Completion: January 9, 2025
• Study Completion (Estimated): January 9, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)