NCT05189171

MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer

MicroOrganoSphere Drug Screen to Lead Care (MODEL) Precision Oncology Pilot Trial in Colorectal Cancer (CRC)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Xilis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	MicroOrganoSphere (MOS) drug screen	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.

Timeline

• Start date: 2022-10-25
• Primary completion: 2023-11-03
• Completion: 2024-03-18
• First posted: 2022-01-12
• Last updated: 2024-06-28

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study