Trial intelligence / Profile preview

RAINFOL-01: Phase 1/2 Study of Rina-S in Advanced Solid Tumors

jRCT2051250094Phase 2Recruiting

Sponsor
Genmab
Start
Oct 2025
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
01

Overview

Phase 2, open-label trial of rinatabart sesutecan in endometrial cancer (EC), Cervical Cancer (CC), ovarian cancer and 3 more (4 arms), sponsored by Genmab. Primary endpoints: Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] - Part B, Objective Response Rate (ORR) by BICR per RECIST v1.1 - Part F and 2 more. Started Oct 2025; status: recruiting.

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Drugs

rinatabart sesutecan
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Conditions

endometrial cancer (EC)Cervical Cancer (CC)ovarian cancerprimary peritoneal cancer (PPC)fallopian tube cancer (PFTC)

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