# Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refracto

Source: https://onco.cc/trials/nct07147231/  
OnCo record `nct07147231` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of cemiplimab in colorectal cancer, run by National Cancer Institute (NCI), now recruiting.

## Summary

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 is a phase 1/2, randomised interventional study registered as NCT07147231 by National Cancer Institute (NCI), with a registry enrolment figure of 86 participants, started 2026-08-10 and due to reach its primary completion in 2027-09-30. Interventions recorded: Biopsy Procedure; Biospecimen Collection; Cemiplimab; Computed Tomography; Magnetic Resonance Imaging; Pidnarulex; Positron Emission Tomography. Conditions listed: Metastatic Colorectal Adenocarcinoma; Refractory Colorectal Adenocarcinoma; Stage III Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Unresectable Colorectal Adenocarcinoma. Primary outcome: Recommended phase 2 dose (RP2D) of pidnarulex (CX-5461) with anti-programmed cell death protein 1 (anti-PD-1) (Phase 1); Incidence of adverse events, serious adverse events, and dose limiting toxicities; Progression-free survival (PFS) (Phase II). Colorectal eligibility wording from the registry: "* Patients must have pathologically confirmed colorectal adenocarcinoma that is unresectable and/or metastatic and for which standard curative or palliative measures do not exist or are no longer effective". Sites: United States. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT07147231
- Phase: 1/2
- Setting: 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)
- Enrolled: 86

## Sources

- ClinicalTrials.gov NCT07147231: https://clinicaltrials.gov/study/NCT07147231

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Cemiplimab](https://onco.cc/drugs/cemiplimab/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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