MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer (MODEL-CRC)

Xilis

Status

Completed

Conditions

Colorectal Neoplasms

Treatments

Device: MicroOrganoSphere (MOS) drug screen

Study type

Observational

Funder types

Industry

Identifiers

NCT05189171

146057.60

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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
1. is scheduled for or plans to be scheduled for a biopsy of the liver OR
2. has a previous histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon and/or rectum that is metastatic to the liver.

Key Exclusion Criteria:

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:
1. 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
2. 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.