Study on AMB-05X for Patients with ctDNA Positive Colorectal Cancer After Treatment Aimed at Cure

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06617858

Provider View

This clinical trial is exploring the effectiveness of a new drug, AMB-05X, in patients with colorectal cancer who have completed treatment aimed at curing the disease but still show signs of cancer through a specific blood test (ctDNA positive).

Patient Parameters

Program Overview

The purpose of this study is to see if the drug AMB-05X can help clear cancer signs in the blood (ctDNA) in patients with colorectal cancer who have finished their main treatments and show no visible signs of cancer on scans. The study will also look at how safe the drug is, how it affects the body, and how it might change over time in the blood. Researchers will also explore how changes in ctDNA relate to patient outcomes and gather information from blood and tissue samples to understand the drug's effects better.

Description

The main goal of this study is to find out how well AMB-05X can clear ctDNA from the blood in patients with stages I-IV colorectal cancer (CRC) who have completed their main treatments and still have ctDNA in their blood. Researchers will also look at how long patients remain free of disease and their overall survival over two years after treatment with AMB-05X. The study will assess the safety and tolerability of AMB-05X and how the drug behaves in the body. Additionally, the study will explore how changes in ctDNA levels relate to patient outcomes and gather data on drug interactions and immune responses from blood and tissue samples.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of colon or rectal cancer.
  • Completed all planned treatments aimed at curing the cancer, with no evidence of disease on scans or clinical exams at least 28 days after treatment.
  • Positive ctDNA blood test at least 28 days after completing all planned treatments.
  • Adequate organ and bone marrow function, including specific blood cell counts and liver and kidney function.
  • ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Aged 18 years or older.
  • Ability to understand and willingness to sign informed consent.
  • Agree to use effective contraception during the study and for 90 days after the last dose of AMB-05X, if applicable.

Exclusion Criteria

  • Other cancers within the last 3 years that could interfere with the study.
  • Significant liver disease that increases treatment risk.
  • Chronic hepatitis B or C infections unless well-controlled or cured.
  • Other health conditions that could affect study participation.
  • Severe side effects from previous cancer treatments, except for hair loss or nerve damage.
  • History of severe allergic reactions to similar treatments.
  • Pregnant or breastfeeding women due to potential risks to the baby.
  • Current treatment with other cancer therapies or investigational drugs.
  • Recent use of certain medications targeting specific cancer pathways.
  • Mental health or social issues that could affect study compliance.

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