Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT06617858
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.
Detailed Description:
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 AMB-05X.
To determine the safety and tolerability of AMB-05X patients with stage I-IV CRC with detectable ctDNA after completion of standard of care, curative-intent therapies.
To characterize the pharmacokinetic profile of AMB-05X in patients with stage I-IV CRC who have ctDNA(+) MRD.
To correlate patterns of ctDNA change with clinical outcomes following treatment with AMB05X in patients with CRC who have detectable ctDNA after completion of standard therapies.
To associate clinical outcomes with PK, PD, anti-drug antibodies, and biomarkers obtained from tissue and blood samples.
Study:
NCT06617858
Study Brief:
Protocol Section:
NCT06617858