Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06617858

Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment

Led by M.D. Anderson Cancer Center · Updated on 2026-04-16

15

Participants Needed

1

Research Sites

164 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To investigate the efficacy of AMB-05X in patients with CRC with MRD as determined by a ctDNA(+) blood test and no clinically detectable radiographic disease.

CONDITIONS

Official Title

Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic or pathologic confirmation of adenocarcinoma of the colon or rectum.
  • Completion of curative intent therapies resulting in no evidence of disease for stage I-IV colorectal cancer.
  • No measurable radiographic or clinically detectable disease at least 28 days after completing standard treatments.
  • Positive ctDNA assay at least 28 days after completing all planned standard treatments.
  • Adequate organ and marrow function including neutrophil count of at least 1,000/mcL, platelets at least 75,000/mcL, hemoglobin above 9.0 g/dL, bilirubin within normal limits, liver enzymes no more than 1.5 times normal, and creatinine clearance of at least 50 mL/min.
  • ECOG performance status of 0 or 1.
  • Age 18 years or older at informed consent.
  • Ability to understand and willingness to sign informed consent.
  • Agreement to use adequate contraception during the study and for 90 days after last dose if of child-bearing potential or male.
  • Approved birth control methods include hormonal contraception, IUD, surgical sterilization, vasectomy, injectable contraceptives, and condoms plus spermicide.
Not Eligible

You will not qualify if you...

  • Prior or concurrent malignancy within 3 years that could interfere with safety or efficacy assessments.
  • Clinically significant liver or biliary disease posing treatment risk.
  • Active hepatitis B infection without undetectable viral load on therapy.
  • Untreated or active hepatitis C infection.
  • Significant autoimmune or cardiovascular disorders as judged by the investigator.
  • Persistent moderate or worse adverse events (grade 2 or higher) from prior cancer therapy, excluding hair loss and neuropathy.
  • Other diseases, metabolic disorders, or lab abnormalities that may increase risk or prohibit use of the study drug.
  • History of severe allergic reactions to human or humanized monoclonal antibodies.
  • Pregnancy or breastfeeding.
  • Concurrent treatment with other systemic anti-cancer agents or investigational drugs.
  • Use of certain tyrosine kinase inhibitors or biologics targeting CSF1 or CSF1R within the past 4 weeks.
  • Psychiatric illness or social situations limiting compliance with study requirements.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

V

Van Morris, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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