{"entity":{"id":"nct07147231","kind":"trial","name":"Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refracto","aka":[],"tldr":"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.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07147231","url":"https://clinicaltrials.gov/study/NCT07147231"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["cemiplimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07147231/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"cemiplimab","kind":"drug","name":"Cemiplimab","route":"/drugs/cemiplimab/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}