RecruitingPhase 1Phase 2NCT07147231

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

A Phase 1 and Randomized Phase 2 Trial of Pidnarulex (CX-5461) and Cemiplimab (REGN2810) in Refractory Microsatellite Stable Colorectal Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

86 participants

Start Date

Dec 21, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Biopsy Procedure, a procedure called Biospecimen Collection, and others for people with metastatic colorectal adenocarcinoma, refractory colorectal adenocarcinoma, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

BIOLOGICALCemiplimab

Given IV

PROCEDUREComputed Tomography

Undergo CT or PET/CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGPidnarulex

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(1)

JHU Sidney Kimmel Comprehensive Cancer Center LAO

Baltimore, Maryland, United States

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NCT07147231


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