{"entity":{"id":"cfi-402257","kind":"drug","name":"CFI-402257","aka":[],"tldr":"CFI-402257 is an experimental small molecule from Treadwell Therapeutics, in phase 2 trials for HR-positive / HER2-negative breast cancer, HER2-negative breast cancer and advanced solid tumours.","summary":"CFI-402257 is a small molecule from Treadwell Therapeutics. A potent and selective small-molecule inhibitor of TTK, tested alone in solid tumours and with fulvestrant or paclitaxel in breast cancer. Its furthest stage is phase 2, for HR-positive / HER2-negative breast cancer, HER2-negative breast cancer and advanced solid tumours. ClinicalTrials.gov registers it in 4 studies linked below. NCT05251714 (Treadwell, phase 1/2) and NCT03568422 (CCTG IND.236) active, not recruiting; NCT05601440 (CCTG platform, phase 2) 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: clinicaltrials.gov","url":"https://clinicaltrials.gov/api/v2/studies/NCT05251714"},{"label":"ClinicalTrials.gov: trials of CFI-402257","url":"https://clinicaltrials.gov/search?intr=CFI-402257"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","breast-cancer","metastatic-cancer"],"sections":[],"technologies":[],"targets":["ttk"],"drugs":[],"companies":["treadwell-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05251714","nct03568422","nct02792465","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-402257","modality":"Small molecule","mechanism":"A potent and selective small-molecule inhibitor of TTK, tested alone in solid tumours and with fulvestrant or paclitaxel in breast cancer.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/cfi-402257/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"target":[{"id":"ttk","kind":"target","name":"MPS1 (TTK)","route":"/targets/ttk/"}],"company":[{"id":"treadwell-therapeutics","kind":"company","name":"Treadwell Therapeutics","route":"/companies/treadwell-therapeutics/"}],"trial":[{"id":"nct02792465","kind":"trial","name":"A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors","route":"/trials/nct02792465/"},{"id":"nct03568422","kind":"trial","name":"CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer","route":"/trials/nct03568422/"},{"id":"nct05251714","kind":"trial","name":"CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer","route":"/trials/nct05251714/"},{"id":"nct05601440","kind":"trial","name":"Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer","route":"/trials/nct05601440/"}]}}