Clinical trialNCT07147231RecruitingPhase 1/PHASE2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment86Metastatic Colorectal AdenocarcinomaRefractory Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Unresectable Colorectal Adenocarcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Wells A Messersmith
JHU Sidney Kimmel Comprehensive Cancer Center LAO
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Benjamin A. Weinberg
Recruiting
Emory Saint Joseph'S Hospital
Atlanta, Georgia, United States
Olumide B. Gbolahan
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Olumide B. Gbolahan
Recruiting
Emory University Hospital/winship Cancer Institute
Atlanta, Georgia, United States
Olumide B. Gbolahan
Recruiting
Johns Hopkins University/sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Eric Christenson
Recruiting
University of Maryland/greenebaum Cancer Center
Baltimore, Maryland, United States
Daniel Shu
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cemiplimab →Pidnarulex

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 10 Aug 2026
Primary completion: 30 Sept 2027
Completion: 30 Sept 2027
Last update posted: 13 Aug 2026
Registered enrollment: 86
Registry id: NCT07147231

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.