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NCT07363408 · ClinicalTrials.gov registry record · Phase 1
Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07363408 is a Phase 1 study that has not yet begun recruiting, run by City of Hope Medical Center. The registered enrollment target is 30 participants.
The verdict
NCT07363408, a Phase 1 study, has not yet begun recruiting, sponsored by City of Hope Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This phase I trial studies the safety, side effects, and best dose of ADG126, in combination with ivonescimab alone, in combination with ivonescimab, leucovorin, and fluorouracil, or in combination with ivonescimab and leucovorin, fluorouracil, and irinotecan (FOLFIRI regimen) in treating patients with microsatellite stable (MSS) colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as ivonescimab and ADG126, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivonescimab may also stop or slow the cancer by blocking the growth of new blood vessels necessary for tumor growth. Leucovorin calcium is a type of drug called a folic acid analog, which means it is similar to the vitamin folic acid. It is used in combination with certain chemotherapy drugs to enhance their ability to kill tumor cells or to lessen their harmful side effects. Fluorouracil is a type of chemotherapy called an antimetabolite, which is a drug that mimics a natural chemical and prevents its use in cells. It interferes with the production of a key component of deoxyribonucleic acid (DNA), which prevents the DNA from copying itself. This causes tumor cells and other rapidly dividing cells to die. Fluorouracil also gets incorporated into ribonucleic acid (RNA) and DNA, disrupting critical cell functions. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Giving ADG126 with ivonescimab, with or without leucovorin and fluorouracil or FOLFIRI regimen, may be safe in treating patients with MSS advanced/metastatic colorectal cancer.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Fluorouracil
- DRUG Irinotecan
- BIOLOGICAL Ivonescimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-07-21 |
| Est. Completion | 2027-07-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07363408
The ClinicalTrials.gov registry entry for NCT07363408 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07363408 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07363408 about?
NCT07363408 is a clinical study titled "Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer". This phase I trial studies the safety, side effects, and best dose of ADG126, in combination with ivonescimab alone, in combination with ivonescimab, leucovorin, and fluorouracil, or in combination with ivonescimab and leucovorin, fluorouracil, and irinotecan (FOLFIRI regimen) in treating patients w...
What is the current status of trial NCT07363408?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-07-21. Estimated completion is 2027-07-21.
What interventions are being tested in trial NCT07363408?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Fluorouracil (DRUG), Irinotecan (DRUG), Ivonescimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07363408?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
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