{"entity":{"id":"nct05462236","kind":"trial","name":"MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer","aka":[],"tldr":"A phase 2 trial of pembrolizumab and fOLFIRI (5-FU, leucovorin, irinotecan) in colorectal cancer, run by AUM Biosciences Pte Ltd, now recruiting.","summary":"MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer is a phase 2, randomised interventional study registered as NCT05462236 by AUM Biosciences Pte Ltd, with a registry enrolment figure of 120 participants, started 2023-04-14 and due to reach its primary completion in 2024-09-30. Interventions recorded: Tinodasertib; Pembrolizumab; Irinotecan. Conditions listed: Metastatic Colorectal Cancer. Primary outcome: Adverse events and Serious Adverse events; Incidence of DLT events and treatment emergent AEs (TEAEs); Objective response rate based on Response Evaluation Criteria in Solid tumors (RECIST) Version 1.1. Colorectal eligibility wording from the registry: \"Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor, and was discontinued from that treatment due to a Grade 3 or higher irAE\". Sites: Australia. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05462236","url":"https://clinicaltrials.gov/study/NCT05462236"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","colon-cancer"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":["pembrolizumab","folfiri"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05462236","phase":"2","setting":"A Phase II Open Label, Dose-finding run-in and Cohort Expansion Study to Evaluate the Safety, Tolerability and Effectiveness of Tinodasertib in Combination With Pembrolizumab or Irinotecan in Metastatic Colorectal Cancer","sponsor":"AUM Biosciences Pte Ltd","enrolled":120,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05462236/","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":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"folfiri","kind":"drug","name":"FOLFIRI (5-FU, leucovorin, irinotecan)","route":"/drugs/folfiri/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}