Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment (NCT06617858)

Usually NOT eligible if any of the following apply:

• Exclusion Criteria:
• 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.