{"entity":{"id":"rainfol-01","kind":"trial","name":"RAINFOL-01 (Rina-S)","aka":[],"tldr":"A next-generation folate-receptor ADC that works even in tumours with low folate receptor, with responses in both ovarian and endometrial cancer.","summary":"Ovarian cohort: confirmed ORR 55.6% at 120 mg/m² (n=20) and 22.7% at 100 mg/m² (n=22) with long follow-up; endometrial cohort (n=64, after anti-PD-1 and platinum): ORR 50% at 100 mg/m² including complete responses, earning Breakthrough Therapy designation. Phase 3 RAINFOL-02 in platinum-resistant ovarian cancer is enrolling, with primary completion expected in 2027. Unlike mirvetuximab, benefit is not restricted to FRα-high tumours.","status":"active","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05579366","url":"https://clinicaltrials.gov/study/NCT05579366"}],"tags":[],"related":[],"cancers":["ovarian","endometrial"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["folr1"],"drugs":["rinatabart-sesutecan"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05579366","phase":"1/2","setting":"Advanced ovarian and endometrial cancer, heavily pretreated: rinatabart sesutecan (FRα ADC, exatecan payload) across FRα expression levels","sponsor":"Genmab","result":"ORR 55.6% (ovarian, 120 mg/m²); 50% (endometrial, 100 mg/m²).","started":"2022-12-07","startedType":"actual","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, ovarian, 120 mg/m²","unit":"%","arms":[{"name":"Rina-S","n":20,"value":55.6}],"source":"https://www.cancernetwork.com/view/rina-s-elicits-encouraging-antitumor-activity-in-advanced-ovarian-cancer"},{"endpoint":"Objective response rate, endometrial, 100 mg/m²","unit":"%","arms":[{"name":"Rina-S","value":50}],"source":"https://www.cancernetwork.com/view/rina-s-earns-fda-breakthrough-therapy-designation-in-endometrial-cancer"}]},"route":"/trials/rainfol-01/","neighbours":{"cancer":[{"id":"advanced-recurrent-endometrial-cancer","kind":"cancer","name":"Advanced or recurrent endometrial cancer","route":"/cancers/advanced-recurrent-endometrial-cancer/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"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/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"target":[{"id":"folr1","kind":"target","name":"Folate receptor alpha","route":"/targets/folr1/"}],"drug":[{"id":"rinatabart-sesutecan","kind":"drug","name":"Rinatabart sesutecan","route":"/drugs/rinatabart-sesutecan/"}],"company":[{"id":"genmab","kind":"company","name":"Genmab","route":"/companies/genmab/"}]}}