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

ClinicalTrials.gov ID: NCT07147231

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.

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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
Lead sponsor: National Cancer Institute (NCI); NIH
Enrollment: 86 participants

Conditions and interventions

Conditions

Interventions

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 9, 2026
Primary completion: Sep 29, 2027
Completion: Sep 29, 2027
Last update posted: Aug 12, 2026

2026 – 2027

United States locations

U.S. sites: 6
U.S. states: 3
U.S. cities: 3

Facility	City	State	ZIP	Site status
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 Aug 12, 2026 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07147231 live on ClinicalTrials.gov.

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