Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refractory Microsatellite Stable Colorectal Cancer
Public ClinicalTrials.gov record NCT07147231. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 and Randomized Phase 2 Trial of Pidnarulex (CX-5461) and Cemiplimab (REGN2810) in Refractory Microsatellite Stable Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I/II trial studies the side effects and best dose of pidnarulex when given together with cemiplimab and to see how well it works in treating patients with microsatellite stable (MSS) colorectal cancer (CRC) that does not respond to treatment (refractory). Pidnarulex may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pidnarulex with cemiplimab may be safe, tolerable and/or effective in treating patients with refractory MSS CRC.
Study identification
- NCT ID
- NCT07147231
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 86 participants
Conditions and interventions
Conditions
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Cemiplimab Biological
- Computed Tomography Procedure
- Magnetic Resonance Imaging Procedure
- Pidnarulex Drug
- Positron Emission Tomography Procedure
Procedure · Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 10, 2026 (Actual)
- Primary completion
- Sep 30, 2027 (Estimated)
- Completion
- Sep 30, 2027 (Estimated)
- Last update posted
- Sep 9, 2026
2026 – 2027
United States locations
- U.S. sites
- 7
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | Recruiting |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | Recruiting |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | Recruiting |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | Recruiting |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | Recruiting |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | Recruiting |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07147231, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07147231 live on ClinicalTrials.gov.