# Rinatabart sesutecan

Source: https://onco.cc/drugs/rinatabart-sesutecan/  
OnCo record `rinatabart-sesutecan` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Rinatabart sesutecan is a next-generation folate-receptor ADC with a topoisomerase payload that responds in both ovarian and endometrial cancer regardless of receptor level.

## Summary

Genmab (via ProfoundBio, 2024). RAINFOL-01: ORR 55.6% in ovarian cancer at 120 mg/m² and 50% in heavily pretreated endometrial cancer at 100 mg/m², the latter earning Breakthrough Therapy designation. Phase 3 RAINFOL-02 versus chemotherapy in platinum-resistant ovarian cancer is enrolling. Neutropenia and anaemia are dose-limiting; ocular toxicity is minimal compared with mirvetuximab.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-07
- Code: Rina-S, PRO1184
- Modality: ADC
- Mechanism: Anti-FRα IgG1 with a hydrophilic linker carrying exatecan; bystander killing extends activity to FRα-low tumours.
- Payload: Exatecan (TOP1 inhibitor), DAR 8
- Linker: Hydrophilic cleavable (ProfoundBio)

## Sources

- ClinicalTrials.gov NCT05579366 (RAINFOL-01 (Rina-S)): https://clinicaltrials.gov/study/NCT05579366

## Connected records

- cancers: [Advanced or recurrent endometrial cancer](https://onco.cc/cancers/advanced-recurrent-endometrial-cancer/), [Endometrial cancer](https://onco.cc/cancers/endometrial/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Platinum-resistant ovarian cancer](https://onco.cc/cancers/platinum-resistant-ovarian-cancer/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- targets: [Folate receptor alpha](https://onco.cc/targets/folr1/)
- companies: [Genmab](https://onco.cc/companies/genmab/)
- trials: [An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Can](https://onco.cc/trials/nct07604766/), [RAINFOL-01 (Rina-S)](https://onco.cc/trials/rainfol-01/), [Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer](https://onco.cc/trials/nct07166094/), [Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer](https://onco.cc/trials/nct07288177/), [Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Re](https://onco.cc/trials/nct07225270/), [Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or](https://onco.cc/trials/nct07564141/), [Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer](https://onco.cc/trials/nct06619236/)
- ideas: [Sequence folate-receptor ADCs by payload class](https://onco.cc/ideas/idea-fra-adc-sequencing-ovarian/)

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