M.D. Anderson Cancer Center
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.
Primary Objective: To determine ctDNA clearance rate at 6 months after treatment with AMB-05X in patients with stages I-IV CRC who have ctDNA(+) status after completion of standard of care, curative-intent therapies. Exploratory Objectives: To estimate 2-year DFS in patients with stage I-IV CRC with detectable ctDNA after completion of standard of care, curative-intent therapies) upon treatment with 6 months of AMB-05X. To estimate 2-year OS in patients with stage I-IV CRC with detectable ctDNA after completion of standard of care, curative-intent therapies) upon treatment with 6 months of…
Inclusion Criteria: 1. Histologic or pathologic confirmation of adenocarcinoma of the colon or rectum. 2. 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. 3. 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…
Given by IV
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