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NCT05672316 · ClinicalTrials.gov registry record · Phase 1
Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy
A Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05672316 is a Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8 that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 28 participants, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05672316, a Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial tests how well botensilimab, balstilimab, and regorafenib works in treating patients with microsatellite stable colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who have progressed on prior chemotherapy. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Regorafenib binds to and inhibits growth factor receptors, which may inhibit the growth of new blood vessels that tumors need to grow. Giving botensilimab, balstilimab, and regorafenib in combination may work better in treating patients with metastatic colorectal cancer than giving these drugs alone.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Regorafenib
- BIOLOGICAL Botensilimab
- BIOLOGICAL Balstilimab
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2023-05-11 |
| Est. Completion | 2026-08-25 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05672316
The ClinicalTrials.gov registry entry for NCT05672316 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (74% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Stage IV Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05672316 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05672316 about?
NCT05672316 is a clinical study titled "Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy". This phase I/II trial tests how well botensilimab, balstilimab, and regorafenib works in treating patients with microsatellite stable colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that may have spread from where it first star...
What is the current status of trial NCT05672316?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2023-05-11. Estimated completion is 2026-08-25.
What conditions does trial NCT05672316 study?
This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Metastatic Colorectal Adenocarcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Advanced Colorectal Adenocarcinoma.
What interventions are being tested in trial NCT05672316?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Regorafenib (DRUG), Botensilimab (BIOLOGICAL), Balstilimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05672316?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05672316 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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