Investigational Drug
Rinatabart sesutecan
TrialFetch AI Analysis
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Overview
Rinatabart sesutecan (Rina-S; GEN1184, formerly PRO1184) is an investigational antibody–drug conjugate being studied in ovarian, endometrial and other solid tumors. Human results are available from the single-arm phase 1/2 RAINFOL-01 study, but randomized trials have not yet established whether it improves outcomes compared with other treatments. (clinicaltrials.gov)
Mechanism of action
Rina-S targets folate receptor alpha (FRα) and carries exatecan, a topoisomerase I inhibitor, through a hydrophilic, protease-cleavable linker. (ascopubs.org)
Efficacy
- Ovarian cancer: In a small dose-expansion cohort of heavily pretreated patients, the confirmed objective response rate at 120 mg/m² every three weeks was 55.6% (95% CI, 30.8–78.5). More than 90% of patients in the cohort had platinum-resistant disease. (international-journal-of-gynecological-cancer.com)
- Endometrial cancer: An ASCO abstract reported unconfirmed response rates of 50% at 100 mg/m² (22 evaluable patients) and 45.5% at 120 mg/m² (33 evaluable patients). The short follow-up and unconfirmed responses limit interpretation. (ascopubs.org)
Safety
In the endometrial-cancer cohort (64 treated patients across both doses), grade 3–4 neutropenia occurred in 48.4%, anemia in 35.9%, and thrombocytopenia in 21.9%. Treatment-emergent adverse events led to dose reduction in 15.6% and discontinuation in 3.1%; investigators assessed one fatal event as treatment-related, although comorbidities complicated that assessment. (ascopubs.org)
Further reading
- RAINFOL-01 phase 1/2 trial record (clinicaltrials.gov)
- Ovarian-cancer results summarized in a published trial abstract (international-journal-of-gynecological-cancer.com)
- Endometrial-cancer phase 1/2 results (ASCO abstract) (ascopubs.org)
Last updated: Sep 2026
Active trials using Rinatabart sesutecan
Found 5 active trials using this drug:
TrialFetch AI summary: For patients with measurable, platinum-sensitive recurrent high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer after first-line carboplatin/paclitaxel, this study compares second-line rinatabart sesutecan (Rina-S), with or without bevacizumab, against investigator-selected platinum-based chemotherapy, with or without bevacizumab. Rina-S is a folate receptor alpha–targeted antibody-drug conjugate that delivers a topoisomerase I inhibitor.
ClinicalTrials.gov ID: NCT07564141
TrialFetch AI summary: Patients with progressive, unresectable locally advanced or metastatic lung adenocarcinoma and ECOG performance status 0–1 receive rinatabart sesutecan monotherapy. This investigational folate receptor alpha–targeted antibody–drug conjugate delivers exatecan, a topoisomerase I inhibitor.
ClinicalTrials.gov ID: NCT07288177
TrialFetch AI summary: Patients with recurrent or progressive endometrial cancer after 1–3 prior lines of therapy, including platinum-based chemotherapy and a PD-(L)1 inhibitor, are randomized to rinatabart sesutecan or investigator-selected paclitaxel or doxorubicin. Rinatabart sesutecan is an investigational folate receptor alpha–targeting antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.
ClinicalTrials.gov ID: NCT07166094
TrialFetch AI summary: Patients with recurrent platinum-sensitive high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer who have complete response, partial response, or stable disease after second-line platinum chemotherapy are randomized to maintenance rinatabart sesutecan plus standard of care or standard of care alone. Rinatabart sesutecan is a folate receptor alpha–targeting antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan; standard of care is bevacizumab maintenance or observation.
ClinicalTrials.gov ID: NCT07225270
TrialFetch AI summary: Adults with previously treated unresectable or metastatic solid tumors, including selected ovarian, endometrial, breast, non-small cell lung cancer, and mesothelioma populations, receive Rina-S alone or with carboplatin, bevacizumab, or pembrolizumab. Rina-S is an investigational FRα-targeting antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.
ClinicalTrials.gov ID: NCT05579366
