Rina-S

DRUG8 trials

Sponsors

Genmab

Conditions

Breast AdenocarcinomaEndometrial CancerEpidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)Fallopian Tube CancerGastrointestinal CancersHigh Grade Epithelial Ovarian CancerHigh Grade Serous Ovarian CancerHormone Receptor-positive/Her2 Negative Breast Cancer

Phase 1

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

RecruitingNCT05579366

GenmabBreast Adenocarcinoma, Endometrial Cancer, Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC) +12

Start: 2022-12-07End: 2027-10-01Target: 764Updated: 2026-04-07

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: 2026-05-12

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: 2026-05-13

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: 2028-05-23Target: 530Updated: 2026-04-29

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: 2026-05-06

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: 2030-04-01Target: 528Updated: 2026-05-05

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

Not yet recruitingNCT07564141

GenmabOvarian Cancer, Platinum-Sensitive Ovarian Cancer

Start: 2026-07-01End: 2031-11-01Target: 688Updated: 2026-05-04

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

Not yet recruitingNCT07604766

GenmabPlatinum-resistant Ovarian Cancer

Start: 2026-06-01End: 2028-12-01Target: 82Updated: 2026-05-22

Related Papers

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