Clinical Trial

Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

Study acronym: RAINFOL-01
Recruiting Phase 1/2
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Summary
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-05-27
notable Enrollment increased: 764 -> 884 participants 2026-05-27
Trial Details
NCT Number NCT05579366
Lead Sponsor Genmab
Conditions High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC), Mesothelioma +7 more
Enrollment 884 participants
Start Date 2022-12-07
Primary Completion 2027-07 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-04