Study Comparing Precemtabart Tocentecan With or Without Bevacizumab to Trifluridine/Tipiracil Plus Bevacizumab in Patients with Previously Treated Metastatic Colorectal Cancer

Sponsor: EMD Serono Research & Development Institute, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07549412

Provider View

This clinical trial is testing a new treatment option for patients with metastatic colorectal cancer who have already received certain standard treatments. The study aims to see if the new treatment can help patients live longer compared to the current standard treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new drug, precemtabart tocentecan (Precem-TcT), either alone or combined with bevacizumab, can help patients with metastatic colorectal cancer live longer than the current treatment option, which is trifluridine/tipiracil (FTD-TPI) plus bevacizumab. This study is for patients whose cancer has spread and who have already been treated with specific chemotherapy drugs but need more options.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of metastatic colorectal cancer that has not responded to or has returned after standard treatments.
  • Have received no more than two previous treatment regimens for metastatic cancer.
  • Be in relatively good health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be able to swallow tablets and follow the study's schedule for evaluations.
  • Other specific criteria may apply as defined by the study protocol.

Exclusion Criteria

  • Have not fully recovered from side effects of previous cancer treatments to a mild level.
  • Have had another type of cancer within the last three years.
  • Have known cancer spread to the brain.
  • Have had certain abdominal issues like fistulas, perforations, or abscesses in the last six months.
  • Have severe bowel issues or chronic inflammatory bowel diseases that could affect the absorption of the study drugs.
  • Other specific criteria may apply as defined by the study protocol.

Locations

FACILITYZIPCITYSTATE
Profound Research LLC at Cancer and Leukemia Center48098TroyMichigan

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