{"entity":{"id":"cfi-400945","kind":"drug","name":"CFI-400945","aka":[],"tldr":"CFI-400945 is an experimental small molecule from Treadwell Therapeutics, in phase 2 trials for acute myeloid leukaemia, myelodysplastic syndromes and chronic myelomonocytic leukaemia and other cancers.","summary":"CFI-400945 is a small molecule from Treadwell Therapeutics. A small-molecule inhibitor of PLK4, tested alone and with azacitidine or decitabine in myeloid cancers and alone or with durvalumab in breast cancer. Its furthest stage is phase 2, for acute myeloid leukaemia, myelodysplastic syndromes, chronic myelomonocytic leukaemia and breast cancer. ClinicalTrials.gov registers it in 7 studies linked below. NCT04730258 (Treadwell, phase 1/2, AML/MDS/CMML) is active, not recruiting; Canadian Cancer Trials Group phase 2 trials NCT03624543, NCT04176848, NCT03385655 active, not recruiting and NCT05601440 recruiting (registry, checked 3 Nov 2026). Whether it works in people has not been established unless a trial below reports it.","status":"phase-2","asOf":"2026-11-03","links":[{"label":"Treadwell Therapeutics: treadwelltx.com","url":"https://treadwelltx.com/pipeline/"},{"label":"Treadwell Therapeutics: treadwelltx.com","url":"https://treadwelltx.com/pipeline/"},{"label":"ClinicalTrials.gov: trials of CFI-400945","url":"https://clinicaltrials.gov/search?intr=CFI-400945"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","mds","cmml","breast-cancer","tnbc","prostate","metastatic-cancer"],"sections":[],"technologies":[],"targets":["plk4"],"drugs":[],"companies":["treadwell-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04730258","nct03187288","nct01954316","nct03624543","nct04176848","nct03385655","nct05601440"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"CFI-400945","modality":"Small molecule","mechanism":"A small-molecule inhibitor of PLK4, tested alone and with azacitidine or decitabine in myeloid cancers and alone or with durvalumab in breast cancer.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/cfi-400945/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"cmml","kind":"cancer","name":"Chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms","route":"/cancers/cmml/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"},{"id":"mds","kind":"cancer","name":"Myelodysplastic syndromes / neoplasms (MDS)","route":"/cancers/mds/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"plk4","kind":"target","name":"PLK4","route":"/targets/plk4/"}],"company":[{"id":"treadwell-therapeutics","kind":"company","name":"Treadwell Therapeutics","route":"/companies/treadwell-therapeutics/"}],"trial":[{"id":"nct01954316","kind":"trial","name":"A Study of CFI-400945 Fumarate in Patients With Advanced Cancer","route":"/trials/nct01954316/"},{"id":"nct04730258","kind":"trial","name":"A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML","route":"/trials/nct04730258/"},{"id":"nct04176848","kind":"trial","name":"CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer","route":"/trials/nct04176848/"},{"id":"nct03624543","kind":"trial","name":"CFI-400945 in Patients With Advanced/Metastatic Breast Cancer","route":"/trials/nct03624543/"},{"id":"nct05601440","kind":"trial","name":"Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer","route":"/trials/nct05601440/"},{"id":"nct03385655","kind":"trial","name":"Prostate Cancer Biomarker Enrichment and Treatment Selection","route":"/trials/nct03385655/"},{"id":"nct03187288","kind":"trial","name":"Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS","route":"/trials/nct03187288/"}]}}