Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT06617858
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2024-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Open-label Phase 2 Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-07925 | OTHER | NCI-CTRP Clinical Trials Registry | View |