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Rina-S

DRUG9 trials

Sponsors

Genmab

Conditions

Breast AdenocarcinomaCervical CancerEndometrial CancerEpidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)Fallopian Tube CancerGastrointestinal CancersHigh Grade Epithelial Ovarian CancerHigh Grade Serous Ovarian Cancer

Phase 1

Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
RecruitingNCT05579366
GenmabBreast Adenocarcinoma, Cervical Cancer, Endometrial Cancer +13
Start: 2022-12-07End: 2027-10-01Target: 952Updated: 2026-10-07

Phase 2

Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
RecruitingNCT07288177
GenmabNon-small Cell Lung Cancer (NSCLC)
Start: 2026-01-30End: 2028-11-22Target: 240Updated: 2026-10-06
Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
RecruitingNCT07539311
GenmabGastrointestinal Cancers
Start: 2026-05-11End: 2028-11-01Target: 160Updated: 2026-10-06

Phase 3

Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer
Active, not recruitingNCT06619236
GenmabPlatinum-resistant Ovarian Cancer
Start: 2025-02-07End: 2027-10-01Updated: 2026-09-28
Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer
RecruitingNCT07166094
GenmabEndometrial Cancer, Recurrent or Progressive Endometrial Cancer
Start: 2025-11-28End: 2029-11-01Target: 660Updated: 2026-10-06
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 Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy
RecruitingNCT07225270
GenmabOvarian Cancer, Platinum-sensitive Ovarian Cancer, PSOC
Start: 2026-04-03End: 2030-05-01Target: 544Updated: 2026-10-06
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 Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer
RecruitingNCT07564141
GenmabOvarian Cancer, Platinum-Sensitive Ovarian Cancer
Start: 2026-08-28End: 2031-11-01Target: 688Updated: 2026-10-07
An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China
RecruitingNCT07604766
GenmabPlatinum-resistant Ovarian Cancer
Start: 2026-06-26End: 2028-12-01Target: 82Updated: 2026-10-06
Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care Maintenance Treatment After First-line (1L) Platinum-based Chemotherapy in Participants With Ovarian Cancer
Not yet recruitingNCT07859215
GenmabOvarian Cancer
Start: 2026-11-01End: 2034-07-01Target: 602Updated: 2026-10-05

Related Papers

RAINFOL-04 (ENGOT-OV96/GOG-3134): A phase 3, open-label, randomized study of rinatabart sesutecan (Rina-S) plus standard of care (SOC) vs SOC as maintenance treatment after second-line platinum-based chemotherapy in patients with recurrent platinum-sensitive ovarian cancer.
Journal of Clinical Oncology2026-05-28
RAINFOL-03 (ENGOT-EN-31/GOG-3128): A global, phase 3, open-label, randomized study of rinatabart sesutecan (Rina-S) vs investigator’s choice of chemotherapy in patients with endometrial cancer after platinum-based chemotherapy and programmed death-ligand 1 inhibition.
Journal of Clinical Oncology2026-05-28
Rinatabart sesutecan (Rina-S) for patients with advanced endometrial cancer: First disclosure from dose expansion cohort B2 of the GTC1184-01 study.
Journal of Clinical Oncology2025-05-281 citations
A phase 3, open-label, randomized study of rinatabart sesutecan (Rina-S) vs investigator’s choice (IC) of chemotherapy in patients with platinum-resistant ovarian cancer (PROC).
Journal of Clinical Oncology2025-05-281 citations
Abstract 6880: Rinatabart sesutecan (PRO1184) in combination with standard-of-care therapy exerted potentiated antitumor activity in preclinical cancer models
Cancer Research2025-04-21
708 A phase 1/2 study of rinatabart sesutecan (PRO1184), a novel folate receptor alpha-directed antibody-drug conjugate, in patients with locally advanced and/or metastatic solid tumors
Regular and Young Investigator Award Abstracts2023-10-315 citations
Phase 1/2 study of PRO1184, a novel folate receptor alpha-directed antibody-drug conjugate, in patients with locally advanced and/or metastatic solid tumors.
Journal of Clinical Oncology2023-06-017 citations
Abstract CT244: Phase 1/2 study of PRO1184, a novel folate receptor alpha-directed antibody-drug conjugate, in patients with locally advanced and/or metastatic solid tumors
Cancer Research2023-04-142 citations