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

NCT06617858 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2024-0476NCI-2024-07925
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

AMB-05X

EXPERIMENTAL

Drug: AMB-05X

Interventions

AMB-05X DRUG

Given by IV

AMB-05X

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or pathologic confirmation of adenocarcinoma of the colon or rectum.
• Completion of any curative intent therapies resulting in no evidence of disease (e.g., R0 resection) for stage I - IV CRC and has completed all planned adjuvant/standard therapies per the discretion of the evaluating clinician.
• No evidence of measurable radiographic disease according to RECIST 1.1 criteria (Eisenhauer et al. Eur. J Cancer 2009) and/or clinically detectable disease (i.e., via endoscopy if utilized as part of standard of care assessment) at least 28 days after completion of all planned standard of care treatment.
• A positive ctDNA assay (Signatera) at least 28 days after completion of all planned standard of care treatment. Assays performed at external institutions are accepted.
• Adequate organ and marrow function as defined below:
• absolute neutrophil count: ≥1,000/mcL
• platelets: ≥75,000/mcL
• hemoglobin: .9.0 g/dL
• total bilirubin: ≤ institutional upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT): ≤1.5 × institutional ULN
• Creatinine clearance ≥50 mL/min. Creatinine clearance (CrCl) to be estimated by the Cockcroft-Gault equation as follows: Clcr (mL/min) = \[(140 - age) x (weight in kg) ÷ \[72 x (serum creatinine in mg/dL)\] \[0.85 if female\]
• ECOG performance status (PS) of 0 or 1 (Appendix A).
• Age ≥ 18 years at the time of informed consent for study participation.
• Ability to understand and willingness to sign a written informed consent document.
• The effects of AMB-05X on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 90 days after the last dose of study treatment. (Refer to Pregnancy Assessment Policy

You may not qualify if:

• Prior or concurrent malignancy within 3 years of registration whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen or requires concurrent therapy (examples include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal carcinoma in situ, cervical carcinoma in situ).
• Clinically significant hepatobiliary disease that, at the discretion of the treating investigator, would lead to excessive treatment risk on study.
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Concomitant health conditions including, but not limited to, autoimmune or cardiovascular disorders that are deemed significant in the investigator's judgment.
• Persistent adverse event greater than or equal to grade 2 of the Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 related to prior anti-cancer therapy (with the exceptions of alopecia and neuropathy).
• Coexisting separate disease, metabolic disorder, clinically significant laboratory result, or any other condition that investigators suspect may (a) prohibit use of the investigational product, or (b) put the patient at undue risk of harm.
• History of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
• Pregnant women are excluded from this study because AMB-05X is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AMB-05X, breastfeeding should be discontinued if the mother is treated with AMB-05X. These potential risks may also apply to other agents used in this study
• Concurrent treatment with other systemic anti-cancer agents (e.g., chemotherapy, hormonal therapy, immunotherapy) or other treatments not part of protocol-specified anti-cancer therapy including concurrent investigational agents of any type.
• Use of pexidartinib, any other oral tyrosine kinase inhibitor (e.g., imatinib or nilotinib), or any biologic treatment targeting CSF1 or CSF1R within the past 4 weeks.
• Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Van Morris, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Van Morris, MD

CONTACT

(713) 792-2828; GIClinicalTrials@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)