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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: Active Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8, sponsored by City of Hope Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will conduct a Simon 2-stage optimal design study.
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 |
What the registry record for NCT05672316 still lists
NCT05672316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (74% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Stage IV Colorectal Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05672316's enrollment target sits among peer trials
28 14th of 22 higher than 9 of 22 other Stage IV Colorectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Colorectal Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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