Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617858
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Trial of AMB-05X for Patients With ctDNA Colorectal Cancer After Curative-intent Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open-label Phase 2 Trial of AMB-05X for Patients With ctDNA Colorectal Cancer After Curative-intent Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None