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Rina-S

Phase 3

Endometrial Cancer | Small molecule | Oncology |Genmab A/S|Last Updated: Sep 1, 2026

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment660

FDA Designations

No designations recorded

Clinical trial landscape

Rina-S · 8 trials · 22 indications

Phase 3 5Phase 2 2Phase 1 1
NCT07564141Study 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 CancerPlatinum-Sensitive Ovarian Cancer
RECRUITING688 Analytics
NCT07604766An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in ChinaPlatinum-resistant Ovarian Cancer
RECRUITING82 Analytics
NCT07225270Study 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 ChemotherapyOvarian Cancer
RECRUITING544 Analytics
NCT07166094Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial CancerEndometrial Cancer
RECRUITING660 Analytics
NCT06619236Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian CancerPlatinum-resistant Ovarian Cancer
ACTIVE NOT_RECRUITING530 Analytics
PHASE3RECRUITING
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
Platinum-Sensitive Ovarian CancerUnlock trial analytics
PHASE3RECRUITING
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
Platinum-resistant Ovarian CancerUnlock trial analytics
PHASE3RECRUITING
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
Ovarian CancerUnlock trial analytics
PHASE3RECRUITING
Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer
Endometrial CancerUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer
Platinum-resistant Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)
Up to approximately 3 years
Progression-Free Survival (PFS)
Up to approximately 16 months

PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by Blinded Independent Central Review (BICR)
Up to approximately 3 years
Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)
Up to approximately 3 years
Overall Survival (OS)
Up to approximately 3 years
Confirmed Objective Response Rate (ORR)
Up to approximately 22 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator
Approximately 3 years
Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Through end of treatment, up to approximately 1 year.
Parts A, and D - Dose Limiting Toxicity (DLT)
At the end of Cycle 1 (each cycle is 21 days)

The proportion of participants experiencing DLT.

Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Through end of treatment, up to approximately 1 year.

Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.

Part K (US Participants Only) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings by Holter
Cycles 1 to 3 (each cycle is 21 days)

Secondary Endpoints

Overall Survival (OS)
Up to approximately 5 years
PFS per RECIST v1.1, as Determined by Investigator
Up to approximately 3 years
Objective Response Rate (ORR) per RECIST v1.1
Up to approximately 3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1: Rina-S ± BevacizumabEXPERIMENTALParticipants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
Arm 2: Investigator Choice of Chemotherapy ± BevacizumabACTIVE_COMPARATORParticipants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.
Rina-SEXPERIMENTAL -
Investigator's ChoiceACTIVE_COMPARATOR -
Rina-S + SOCEXPERIMENTALParticipants will receive Rina-S and SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).
SOCACTIVE_COMPARATORParticipants will receive SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).
ICACTIVE_COMPARATORParticipants will receive one of the following chemotherapies at the discretion of the investigator: * Paclitaxel on Days 1, 8, and 15 every 4 weeks (Q4W). * Doxorubicin on Day 1 Q3W.
Part A, B, C, E, F, G, H, I, J and KEXPERIMENTALRina-S monotherapy in Part A and at the recommended dose in Parts B, C, E, F, G, H, I, J and K.
Part D1EXPERIMENTALRina-S in combination with carboplatin
Part D2 and IEXPERIMENTALRina-S in combination with bevacizumab
Part D3 and D4EXPERIMENTALRina-S in combination with pembrolizumab

Interventions

NameTypeDescription
Rina-SBIOLOGICALIntravenous (IV) infusion
BevacizumabDRUGIV infusion
CarboplatinDRUGIV infusion
GemcitabineDRUGIV infusion
PaclitaxelDRUGIV infusion
PLDDRUGIV infusion
TopotecanDRUGIV infusion
Pegylated liposomal doxorubicin (PLD)DRUGIV infusion
ICDRUG* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion
PembrolizumabDRUGPembrolizumab intravenous infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: * Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer. * Participant must have documented recurrence or progression after first-line (1L) platinum-based chemot...

Countries:United StatesChinaJapanAustraliaBelgiumBrazilCanadaDenmarkFinlandFranceGermanyGreeceIsraelItalyLithuaniaNorwayPolandPuerto RicoSingaporeSpainAustriaCzechiaNetherlandsHungaryTaiwan
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Recent Changes (Last 90 Days)

LOWSep 1, 2026NCT07564141startDate: changed
LOWSep 1, 2026NCT07564141startDate: changed
LOWAug 26, 2026NCT07288177lastUpdatePostDate: changed
LOWAug 26, 2026NCT07288177lastUpdatePostDate: changed
LOWAug 17, 2026NCT07166094lastUpdatePostDate: changed
LOWAug 17, 2026NCT07166094lastUpdatePostDate: changed
LOWAug 14, 2026NCT07604766Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 14, 2026NCT07604766Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 12, 2026NCT06619236lastUpdatePostDate: changed
LOWAug 12, 2026NCT06619236lastUpdatePostDate: changed
LOWAug 5, 2026NCT07564141startDate: changed
LOWAug 4, 2026NCT07539311lastUpdatePostDate: changed
LOWAug 4, 2026NCT07225270lastUpdatePostDate: changed
LOWAug 4, 2026NCT07166094lastUpdatePostDate: changed
LOWAug 4, 2026NCT05579366lastUpdatePostDate: changed
LOWAug 4, 2026NCT07288177lastUpdatePostDate: changed
LOWAug 4, 2026NCT07539311lastUpdatePostDate: changed
LOWAug 4, 2026NCT05579366lastUpdatePostDate: changed
LOWAug 4, 2026NCT07288177lastUpdatePostDate: changed
LOWAug 4, 2026NCT07225270lastUpdatePostDate: changed

Frequently asked questions about Rina-S

What is Rina-S used for?

Rina-S is an investigational oncology drug being developed for multiple cancer types, including platinum-resistant ovarian cancer, high grade epithelial ovarian cancer, endometrial cancer, gastrointestinal cancers, and non-small cell lung cancer (NSCLC). It is currently in Phase 3 clinical development for platinum-resistant ovarian cancer.

Who makes Rina-S?

Rina-S is being developed by Genmab A/S, a biopharmaceutical company traded on the Nasdaq under the ticker GMAB. The company is conducting clinical trials for Rina-S across multiple oncology indications, including ovarian cancer and non-small cell lung cancer.

What phase is Rina-S in?

Rina-S is in Phase 3 clinical development for platinum-resistant ovarian cancer, with an active Phase 3 trial (NCT06619236) comparing it to investigator's choice treatment. It is also being studied in Phase 2 for non-small cell lung cancer and in earlier-stage trials for other solid tumors.

What clinical trials is Rina-S in?

Rina-S is being evaluated in multiple trials, including NCT05579366 (Phase 1, advanced solid tumors), NCT06619236 (Phase 3, platinum-resistant ovarian cancer), NCT07225270 (Phase 3, recurrent platinum-sensitive ovarian cancer), and NCT07288177 (Phase 2, non-small cell lung cancer). All trials are actively recruiting or ongoing.

Is Rina-S the same as PRO1184 or GEN1184?

Yes, Rina-S is also known as PRO1184 and GEN1184, as indicated in the Phase 1 trial title for advanced solid tumors. These alternative names refer to the same investigational drug being developed by Genmab.

What is the mechanism of action of Rina-S?

Rina-S is a small molecule oncology drug, but its specific molecular target has not been disclosed in the available clinical trial information. It is being studied across multiple cancer types, suggesting a potentially broad antitumor activity, though the exact mechanism remains under investigation.