{"entity":{"id":"lunresertib","kind":"drug","name":"Lunresertib","aka":["RP-6306"],"tldr":"Lunresertib is an experimental oral small molecule kinase inhibitor from Repare Therapeutics, in phase 2 trials for advanced solid tumours, ER-positive HER2-negative breast cancer resistant to CDK4/6 inhibitors and TP53-mutant ovarian and uterine cancer.","summary":"Lunresertib (RP-6306) is an oral small molecule kinase inhibitor from Repare Therapeutics, with Debiopharm as licensee. A first-in-class oral inhibitor of PKMYT1, a cell-cycle kinase; developed alone and with Debiopharm's WEE1 inhibitor Debio 0123 (zedoresertib). Its furthest stage is phase 2, for advanced solid tumours, ER-positive HER2-negative breast cancer resistant to CDK4/6 inhibitors (platform trial) and TP53-mutant ovarian and uterine cancer (with carboplatin and paclitaxel). ClinicalTrials.gov registers it in 6 studies linked below. Exclusively licensed worldwide to Debiopharm on 15 July 2025; Debiopharm took over sponsorship of the MYTHIC study (NCT04855656, recruiting). Phase 2 use is in the Canadian Cancer Trials Group platform NCT05601440 (recruiting) and NCT05605509 (completed). Whether it works in people has not been established unless a trial below reports it.","status":"phase-2","asOf":"2026-11-03","links":[{"label":"Repare Therapeutics: sec.gov","url":"https://www.sec.gov/Archives/edgar/data/1808158/000119312525159942/d944012dex991.htm"},{"label":"Repare Therapeutics: sec.gov","url":"https://www.sec.gov/Archives/edgar/data/1808158/000119312525159942/d944012dex991.htm"},{"label":"Repare Therapeutics: clinicaltrials.gov","url":"https://clinicaltrials.gov/api/v2/studies/NCT04855656"},{"label":"ClinicalTrials.gov: trials of RP-6306","url":"https://clinicaltrials.gov/search?intr=RP-6306"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["repare-therapeutics","debiopharm"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04855656","nct05601440","nct05605509","nct05147350","nct05147272","nct06107868"],"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":"RP-6306","modality":"Oral small molecule kinase inhibitor","mechanism":"A first-in-class oral inhibitor of PKMYT1, a cell-cycle kinase; developed alone and with Debiopharm's WEE1 inhibitor Debio 0123 (zedoresertib).","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/lunresertib/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"company":[{"id":"debiopharm","kind":"company","name":"Debiopharm","route":"/companies/debiopharm/"},{"id":"repare-therapeutics","kind":"company","name":"Repare Therapeutics","route":"/companies/repare-therapeutics/"}],"trial":[{"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":"nct06107868","kind":"trial","name":"Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer","route":"/trials/nct06107868/"},{"id":"nct05605509","kind":"trial","name":"RP-6306 in Patients With Advanced Cancer","route":"/trials/nct05605509/"},{"id":"nct04855656","kind":"trial","name":"Study of Lunresertib Alone or in Combination With RP-3500 or Zedoresertib (Debio 0123) in Patients With Advanced Solid Tumors","route":"/trials/nct04855656/"},{"id":"nct05147350","kind":"trial","name":"Study of RP-6306 With FOLFIRI in Advanced Solid Tumors","route":"/trials/nct05147350/"},{"id":"nct05147272","kind":"trial","name":"Study of RP-6306 With Gemcitabine in Advanced Solid Tumors","route":"/trials/nct05147272/"}]}}