{"entity":{"id":"nct05870748","kind":"trial","name":"REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1","aka":["REFRaME-O1"],"tldr":"A phase 2/3 trial of Luveltamab tazevibulin, Pegfilgrastim, Gemcitabine, Paclitaxel / nab-paclitaxel, Pegylated liposomal doxorubicin and Topotecan in Ovarian cancer and Platinum-resistant ovarian cancer, run by Sutro Biopharma, Inc., recorded as terminated on the registry.","summary":"REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1 is a phase 2/3 interventional study registered as NCT05870748 by Sutro Biopharma, Inc., with 600 participants recorded, started 2023-07-12 and due to reach its primary completion in 2025-08-26. Interventions recorded: Luveltamab tazevibulin, Pegfilgrastim, Gemcitabine, Paclitaxel, Pegylated liposomal doxorubicin, Topotecan. Conditions recorded: Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-resistant Ovarian Cancer.\n\nLinked to the drug Luveltamab tazevibulin because the registry names it among its interventions and Ovarian cancer and Platinum-resistant ovarian cancer among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05870748","url":"https://clinicaltrials.gov/study/NCT05870748"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["luveltamab-tazevibulin","pegfilgrastim","gemcitabine","paclitaxel","pegylated-liposomal-doxorubicin","topotecan"],"companies":["sutro-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05870748","phase":"2/3","setting":"REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)","sponsor":"Sutro Biopharma, Inc.","participation":[{"nct":"NCT05870748","source":"https://clinicaltrials.gov/study/NCT05870748","fetchedAt":"2026-10-07T16:53:59.307Z","studySha256":"da46d1c11a28b42abc51e3e5d0854df929fc829ac9f03b204135acb57881067b","overallStatus":"TERMINATED","lastUpdatePosted":"2025-09-23","whyStopped":"Due to strategic business considerations, Sutro has deprioritized the development of luveltamab tazevibulin, leading to termination of the REFRaME program. This decision is not related to any safety or efficacy concerns associated with luvelta","leadSponsor":"Sutro Biopharma, Inc.","collaboratorCount":3,"minimumAge":"18 Years","sex":"FEMALE","healthyVolunteers":false,"hasEligibility":true,"enrolment":600,"enrolmentType":"ACTUAL","siteCount":63,"recruitingSiteCount":0,"countries":["Australia","Canada","Israel","New Zealand","Singapore","South Korea","United States"]}],"started":"2023-07-12","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05870748/","neighbours":{"cancer":[{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"platinum-resistant-ovarian-cancer","kind":"cancer","name":"Platinum-resistant ovarian cancer","route":"/cancers/platinum-resistant-ovarian-cancer/"}],"drug":[{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"luveltamab-tazevibulin","kind":"drug","name":"Luveltamab tazevibulin","route":"/drugs/luveltamab-tazevibulin/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"pegfilgrastim","kind":"drug","name":"Pegfilgrastim","route":"/drugs/pegfilgrastim/"},{"id":"pegylated-liposomal-doxorubicin","kind":"drug","name":"Pegylated liposomal doxorubicin","route":"/drugs/pegylated-liposomal-doxorubicin/"},{"id":"topotecan","kind":"drug","name":"Topotecan","route":"/drugs/topotecan/"}],"company":[{"id":"sutro-biopharma","kind":"company","name":"Sutro Biopharma","route":"/companies/sutro-biopharma/"}]}}