OnCo
drugsProductPhase 3

Rinatabart sesutecan

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.

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.

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Payload: exatecan
PubChem
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1.Binds folate receptor alpha on the tumour cell

Modality
ADC
Mechanism
Anti-FRα IgG1 with a hydrophilic linker carrying exatecan; bystander killing extends activity to FRα-low tumours.
Brand / code
Rina-S, PRO1184
Payload
Exatecan (TOP1 inhibitor), DAR 8
Linker
Hydrophilic cleavable (ProfoundBio)
Where it is approved
USunder reviewEUUKJPCNAUcompare regions →

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Regulatory

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  1. 2025DesignationUS

    Breakthrough Therapy designation, advanced endometrial cancer after PD-(L)1 and platinum source

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
8 studies7 recruiting3 Phase 25 Phase 3
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Rinatabart sesutecan
intervention: Rinatabart sesutecan
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Landmark trials in OnCo

RAINFOL-01 (Rina-S)

Latest papers

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Latest papers · live from Europe PMC
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Query for this drug: (TITLE:"Rinatabart sesutecan" OR ABSTRACT:"Rinatabart sesutecan" OR TITLE:"Rina-S" OR ABSTRACT:"Rina-S" OR TITLE:"PRO1184" OR ABSTRACT:"PRO1184") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Rinatabart sesutecan, not a curated reading list.

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cancers

2
Endometrial cancerOvarian cancer

technologies

2
Antibody-drug conjugate (ADC)Topoisomerase-I inhibitors (and ADC payloads)

targets

1
Folate receptor alpha

companies

1
Genmab

trials

1
RAINFOL-01 (Rina-S)

ideas

1
Sequence folate-receptor ADCs by payload class