Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-29 @ 2:13 AM
Study NCT ID:
NCT06959550
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2025-11
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:
The goal of this clinical research study is to learn if ivonescimab can help to control previously treated, metastatic colorectal cancer.
Detailed Description:
Primary Objective:
• To evaluate the efficacy of ivonescimab, as determined by the objective response rate per iRECIST, in three distinct cohorts of patients with treatment-refractory metastatic colorectal cancer: 1) dMMR/MSI-H refractory to anti-PD-1 therapy, 2) pMMR/MSS without liver metastases, and 3) pMMR/MSS with liver metastases.
Secondary Objective:
* To evaluate the safety of ivonescimab in patients with metastatic colorectal cancer.
* To evaluate the efficacy of ivonescimab, as determined by the objective response rate per RECIST 1.1, in three distinct cohorts of patients with treatment-refractory metastatic colorectal cancer: 1) dMMR/MSI-H refractory to anti-PD-1 therapy, 2) pMMR/non-MSI-H without liver metastases, and 3) pMMR/non-MSI-H with liver metastases.
* To evaluate changes in intratumoral CD8+ T cell density following ivonescimab therapy.
Exploratory Objectives:
* To assess the time to response following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To assess the durability of response following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To evaluate progression-free survival following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To evaluate overall survival following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To investigate clinical, pathologic, and molecular features associated with therapeutic response to ivonescimab in patients with metastatic colorectal cancer.
* To investigate changes in immune cell composition and distance relationships within the metastatic CRC tumor microenvironment following ivonescimab therapy.
* To evaluate changes in peripheral immune cell populations in metastatic CRC patients following ivonescimab therapy.
• To evaluate the efficacy of ivonescimab, as determined by the objective response rate per iRECIST, in three distinct cohorts of patients with treatment-refractory metastatic colorectal cancer: 1) dMMR/MSI-H refractory to anti-PD-1 therapy, 2) pMMR/MSS without liver metastases, and 3) pMMR/MSS with liver metastases.
Secondary Objective:
* To evaluate the safety of ivonescimab in patients with metastatic colorectal cancer.
* To evaluate the efficacy of ivonescimab, as determined by the objective response rate per RECIST 1.1, in three distinct cohorts of patients with treatment-refractory metastatic colorectal cancer: 1) dMMR/MSI-H refractory to anti-PD-1 therapy, 2) pMMR/non-MSI-H without liver metastases, and 3) pMMR/non-MSI-H with liver metastases.
* To evaluate changes in intratumoral CD8+ T cell density following ivonescimab therapy.
Exploratory Objectives:
* To assess the time to response following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To assess the durability of response following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To evaluate progression-free survival following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To evaluate overall survival following treatment with ivonescimab in patients with metastatic colorectal cancer.
* To investigate clinical, pathologic, and molecular features associated with therapeutic response to ivonescimab in patients with metastatic colorectal cancer.
* To investigate changes in immune cell composition and distance relationships within the metastatic CRC tumor microenvironment following ivonescimab therapy.
* To evaluate changes in peripheral immune cell populations in metastatic CRC patients following ivonescimab therapy.
Study Oversight
Has Oversight DMC:
True
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-2025-03211 | OTHER | NCI-CTRP Clinical Trials Registry | View |