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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

NCT07147231 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Metastatic Colorectal Adenocarcinoma
  • Refractory Colorectal Adenocarcinoma
  • Stage III Colorectal Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Unresectable 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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Wells A Messersmith · JHU Sidney Kimmel Comprehensive Cancer Center LAO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-21
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07147231 on ClinicalTrials.gov