NCT07147231View on ClinicalTrials.gov

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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

September 1, 2027

Study Completion Date

September 1, 2027

Conditions
Metastatic Colorectal AdenocarcinomaRefractory Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Unresectable Colorectal Adenocarcinoma
Interventions
PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Cemiplimab

Given IV

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Pidnarulex

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH