MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer

NCT05189171 | Completed FDA Device

• 1 other identifier: 146057.60
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of the study is to determine the feasibility of generating sufficient MicroOrganoSpheres (MOS) from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to the liver and completing a drug screen against patient-derived MOS using standard of care drugs used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/capecitabine (Xeloda), bevacizumab, panitumumab or cetuximab, trifluridine/tipiracil (Lonsurf), regorafenib and pembrolizumab or nivolumab) in ≤ 14 days.

Conditions

Colorectal Neoplasms

Keywords

Liver Metastasis; Colorectal Cancer; Colon Cancer; CRC liver metastasis; patient-derived model

Outcome Measures

Primary Outcomes (1)

• MOS generation

  Whether or not MOS could be generated from a biopsy of a patient's colorectal cancer liver metastasis

  <14 Days from start of MOS generation

Study Arms (1)

Metastatic colorectal cancer

Patients having a liver biopsy for suspected adenocarcinoma of the colon and/or rectum that is metastatic to the liver.

Device: MicroOrganoSphere (MOS) drug screen

Interventions

MicroOrganoSphere (MOS) drug screen DEVICE

Patient-derived models of cancer, called MOS, will be generated from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to the liver and a drug screen using standard-of-care drugs used will be completed (oxaliplatin, irinotecan, 5-FU/capecitabine (Xeloda), bevacizumab, panitumumab or cetuximab, trifluridine/tipiracil (Lonsurf), regorafenib and pembrolizumab or nivolumab). Subjects will receive standard-of-care therapy for CRC dictated by their treating physicians.

Metastatic colorectal cancer

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

This study will be open to patients in a medical practice of all demographic groups who meet the eligibility criteria.

You may qualify if:

• Subject signed a valid, Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form.
• Male or female age 18 or older when written informed consent is obtained.
• Study candidate is willing and able to comply with all protocol-required procedures and assessments.
• Study candidate either
• is scheduled for or plans to be scheduled for a biopsy of the liver OR
• has a previous histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon and/or rectum that is metastatic to the liver.

You may not qualify if:

• If already scheduled for a biopsy of the liver: liver biopsy was ordered to help diagnose, determine the severity of, or treat a disease that is unrelated to colorectal cancer (e.g., nonalcoholic fatty liver disease, chronic hepatitis B or C, autoimmune hepatitis, alcoholic liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson's disease, etc.).
• Study candidate is participating (or intends to participate) in another clinical study AND either:
• is currently receiving investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver as part of that study OR
• that study only allows investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver (simultaneous participation in a clinical trial standard of care control arm is allowed, provided the subject is either already randomized or may be randomized to the control arm).
• Confirmed histological or cytological diagnosis of neuroendocrine colorectal cancer.

Sponsors & Collaborators

• Xilis, Inc.: lead

Study Sites (7)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

MedStar Washington Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Inland Imaging

Spokane, Washington, 99208, United States

Location

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Biospecimen

Retention: SAMPLES WITH DNA

A standard-of-care biopsy of the liver metastasis and a blood draw will be used for the purpose of this trial. Where sample size permits, a portion of the sample may be retained.

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Study Official

  Xilis, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 12, 2022
• Study Start: October 25, 2022
• Primary Completion: November 3, 2023
• Study Completion: March 18, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)