# RAINFOL-01 (Rina-S)

Source: https://onco.cc/trials/rainfol-01/  
OnCo record `rainfol-01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-07
- Registry id: 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).
- Outcomes: Objective response rate, ovarian, 120 mg/m²: Rina-S 55.6%; Objective response rate, endometrial, 100 mg/m²: Rina-S 50%

## Sources

- ClinicalTrials.gov NCT05579366: 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/)
- drugs: [Rinatabart sesutecan](https://onco.cc/drugs/rinatabart-sesutecan/)
- companies: [Genmab](https://onco.cc/companies/genmab/)

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