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NCT07147231 · ClinicalTrials.gov registry record · Phase 1

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 study, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
86
Enrollment target

NCT07147231: Recruiting Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT07147231 is a Phase 1 study that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 86 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07147231, a Phase 1 study, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
86 participants
Enrollment target

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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Biopsy Procedure
  • BIOLOGICAL Cemiplimab

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2026-12-21
Est. Completion 2027-09-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT07147231

The ClinicalTrials.gov registry entry for NCT07147231 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT07147231 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT07147231 about?

NCT07147231 is a clinical study titled "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". 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...

What is the current status of trial NCT07147231?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2026-12-21. Estimated completion is 2027-09-30.

What interventions are being tested in trial NCT07147231?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Cemiplimab (BIOLOGICAL).

Who is sponsoring clinical trial NCT07147231?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.