Endometrial CancerPhase 3RAINFOL-03NCT07166094
Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer
A Phase 3 study testing Rina-S and IC in people with Endometrial Cancer and Recurrent or Progressive Endometrial Cancer, run by Genmab at 177 sites in 19 countries.
Trial summary
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Recurrent or Progressive Endometrial Cancer
- What is being tested?
- Rina-S and IC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 177 sitesin 19 countries
- Study dates
- 28 Nov 2025to Nov 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
- Participants must have received at least 1, but not more than 3, prior lines of therapy:
- Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination
- If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.
- Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.
- Prior induction plus maintenance is considered 1 line of therapy
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- Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
- Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)
- Participants must have progressed radiographically on or after their most recent line of therapy
Who cannot join
- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
- Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration).
- Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after completion of brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the planned first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
- Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
- Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Trial locations and contacts
177 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
177 sites in 19 countries
United States69 sites, 69 recruiting
- Recruiting
TX Onc - Arlington North
Arlington, Texas, 76012
- Recruiting
Emory Winship Cancer Inst.
Atlanta, Georgia, 30308
- Recruiting
Emory Winship Cancer Inst.
Atlanta, Georgia, 30322
- Recruiting
Northside Hospital Atlanta
Atlanta, Georgia, 30342
- Recruiting
USOR - Texas Oncology
Austin, Texas, 78731
- Recruiting
USOR - Texas Oncology
Austin, Texas, 78745
- Recruiting
USOR - Texas Oncology- Austin North
Austin, Texas, 78758
- Recruiting
Sinai Hospital
Baltimore, Maryland, 21215
- Recruiting
OLOL Cancer Institute
Baton Rouge, Louisiana, 70808
- Recruiting
TX Onc - Bedford
Bedford, Texas, 76022
- Recruiting
Atrium Health LCI - Morehead
Charlotte, North Carolina, 28204
- Recruiting
Atrium Health LCI - Ballantyne
Charlotte, North Carolina, 28277
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Recruiting
Atrium Health LCI - Concord
Concord, North Carolina, 28025
- Recruiting
USOR - Minnesota Oncology-Coon Rapids Clinic
Coon Rapids, Minnesota, 55433
- Recruiting
USOR - Minnesota Oncology/ Coon Rapids Clinic
Coon Rapids, Minnesota, 55433
- Recruiting
TX Onc - Methodist Dallas
Dallas, Texas, 75203
- Recruiting
TX Onc - Presbyterian Dallas
Dallas, Texas, 75231
- Recruiting
TX Onc - Methodist Charlton
Dallas, Texas, 75237
- Recruiting
TX Onc - Sammons
Dallas, Texas, 75246
- Recruiting
Norwalk Hospital
Danbury, Connecticut, 06810
- Recruiting
Emory Winship Cancer Inst./Emory Decatur Hospital
Decatur, Georgia, 30033
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
- Recruiting
USOR - Minnesota Oncology - Edina Clinic
Edina, Minnesota, 55435
- Recruiting
USOR - Minnesota Oncology/Edina Clinic
Edina, Minnesota, 55435
- Recruiting
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon, 97401
- Recruiting
Endeavor Health NorthShore
Evanston, Illinois, 60201
- Recruiting
USOR - Texas Oncology - Dallas Fort Worth (DFW)
Fort Worth, Texas, 76104
- Recruiting
Atrium Health LCI - Gaston
Gastonia, North Carolina, 28054
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
- Recruiting
NW Cancer Specs. P.C.
Happy Valley, Oregon, 97015
- Recruiting
USOR - Texas Oncology
Harlingen, Texas, 78550
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
- Recruiting
Kaiser Permanente SoCal
Irvine, California, 92618
- Recruiting
USOR - Minnesota Oncology/ Maple Grove Clinic
Maple Grove, Minnesota, 55369
- Recruiting
USOR - Minnesota Oncology-Maplewood Clinic
Maplewood, Minnesota, 55109
- Recruiting
USOR - Minnesota Oncology/ Maplewood Clinic
Maplewood, Minnesota, 55109
- Recruiting
USOR - Texas Oncology
McAllen, Texas, 78503
- Recruiting
USOR - Minnesota Oncology/ Minneapolis Clinic
Minneapolis, Minnesota, 55404
- Recruiting
USOR - Minnesota Oncology
Minneapolis, Minnesota, 55404
- Recruiting
USAH Mitchell Cancer Inst
Mobile, Alabama, 36604
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
- Recruiting
LSU Health New Orleans
New Orleans, Louisiana, 70112
- Recruiting
NYU Laura and Isaac Perlmutter Cancer Center - 34th Street
New York, New York, 10016
- Recruiting
Perlmutter CC NYU Langone LI
New York, New York, 11501
- Recruiting
Norwalk Hospital
Norwalk, Connecticut, 06856
- Recruiting
HonorHealth Research Inst
Phoenix, Arizona, 85016
- Recruiting
USOR - NW Cancer Specs P.C.
Portland, Oregon, 97227
- Recruiting
USOR - TX Oncology - SA NE
San Antonio, Texas, 78217
- Recruiting
NEXT San Antonio
San Antonio, Texas, 78240
- Recruiting
CPMC Research Institute
San Francisco, California, 94109
- Recruiting
SMH - Sarasota - Main Campus
Sarasota, Florida, 34239
- Recruiting
Trials365, LLC
Shreveport, Louisiana, 71103
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
Women's Care - 9th Ave
St. Petersburg, Florida, 33713
- Recruiting
Atlantic Health - Overlook MC
Summit, New Jersey, 07901
- Recruiting
Women's Care - Armenia Ave
Tampa, Florida, 33603
- Recruiting
Holy Name Medical Center
Teaneck, New Jersey, 07666
- Recruiting
USOR - NW Cancer Specs. P.C.
Tigard, Oregon, 97223
- Recruiting
USOR - NW Cancer Specs P.C.
Vancouver, Washington, 98684
- Recruiting
USOR - Texas Oncology- Horizon Circle
Waco, Texas, 76712
- Recruiting
USOR - Texas Oncology- Waco
Waco, Texas, 76712
- Recruiting
MedStar Washington Hospital
Washington D.C., District of Columbia, 20010
- Recruiting
USOR - Texas Oncology
Weslaco, Texas, 78596
- Recruiting
William Kahlert Reg. Can. Ctr
Westminster, Maryland, 21157
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27517
- Recruiting
USOR - Minnesota Oncology/ Woodbury Clinic
Woodbury, Minnesota, 55125
- Recruiting
UMass Memorial Medical Ctr
Worcester, Massachusetts, 01605
Japan20 sites, 20 recruiting
- Recruiting
Chiba University Hospital- Center for Outpatient
Chiba, Chiba, 260-8677
- Recruiting
National Cancer Center Hospital East
Chiba, 277-8577
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1347
- Recruiting
Fukushima Medical University Hospital
Fukushima, 960-1247
- Recruiting
Hyogo Cancer Center
Hyōgo, 673-0021
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777
- Recruiting
Niigata Cancer Center Hospital
Niigata
- Recruiting
Osaka International Cancer Institute - Osaka - Otemae Acti
Osaka, Osaka, 541-8567
- Recruiting
Gunma Prefectural Cancer Center
Ōta, Gunma, 373-8550
- Recruiting
Kitasato University Hospital
Sagamihara-shi, Kanagawa, 252-0373
- Recruiting
Saitama Medical University - International Medical Center
Saitama, 350-1298
- Recruiting
Sapporo Medical University Hospital
Sapporo, 060-8543
- Recruiting
NUC Tohoku Univ. Hospital
Sendai, Miyagi, 980-8574
- Recruiting
Iwate Medical University Hosp
Shiwa-gun, Iwate, 028-3695
- Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686
- Recruiting
Keio University Hospital
Tokyo, Tokyo, 160-8582
- Recruiting
Cancer Institute Hospital of JFCR
Tokyo, 135-8550
- Recruiting
Mie University Hospital
Tsu, Kansai, 514-8507
- Recruiting
Yamagata University Hospital
Yamagata, 990-9585
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Spain16 sites, 16 recruiting
- Recruiting
CHU A Coruña
A Coruña, La Coruña, 15006
- Recruiting
Vall d'Hebron
Barcelona, Catalonia, 08035
- Recruiting
Hospital Clínic BCN
Barcelona, Catalonia, 08036
- Recruiting
Hospital Universitari de Girona Doctor Josep Trueta
Girona, GI, 17007
- Recruiting
CUN Madrid
Madrid, Madrid, 28027
- Recruiting
Hospital 12 de Octubre
Madrid, Madrid, 28041
- Recruiting
HM Sanchinarro
Madrid, Madrid, 28050
- Recruiting
Hospital La Paz
Madrid, 28046
- Recruiting
HU Virgen de la Victoria
Málaga, Málaga, 29010
- Recruiting
H.R.U. Málaga - Materno-Inf.
Málaga, 7120
- Recruiting
Hosp. Univ. Son Espases
Palma de Mallorca, Balearic Islands, 07120
- Recruiting
CUN Pamplona
Pamplona, Navarre, 31008
- Recruiting
HU Virgen del Rocío
Seville, 41013
- Recruiting
HU Virgen de Valme
Seville, 41014
- Recruiting
IVO Valencia
Valencia, Valenciana, Comunidad, 46009
- Recruiting
HU Miguel Servet
Zaragoza, Zaragoza, 50009
France13 sites, 13 recruiting
- Recruiting
ICO Angers
Angers, Pays de la Loire Region, 49055
- Recruiting
CH de la Côte Basque
Bayonne, Pyrénées-Atlantiques, 64109
- Recruiting
Clinique Tivoli Ducos
Bordeaux, Gironde, 33000
- Recruiting
CHU Brest - Cavale Blanche
Brest, Brittany Region, 29609
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, Auvergne-Rhône-Alpes, 63011
- Recruiting
CGFL Dijon
Dijon, Bourgogne-Franche-Comté, 21079
- Recruiting
GHM Grenoble
Grenoble, Auvergne-Rhône-Alpes, 38028
- Recruiting
ICM Montpellier
Montpellier, Occitanie, 34298
- Recruiting
L'Hôpital Privé Nancy Lorraine
Nancy, Meurthe-Et-Moselle, 54000
- Recruiting
CHU Orléans - Pharmacie
Orléans, Loiret, 45067
- Recruiting
Cancer Institute Jean Godinot
Reims, Marne, 51092
- Recruiting
HUS Strasbourg
Strasbourg, Bas-Rhin, 67200
- Recruiting
Hôpital Foch
Suresnes, Île-de-France Region, 92150
Australia7 sites, 7 recruiting
- Recruiting
GenesisCare Campbelltown
Campbelltown, New South Wales, 2560
- Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
- Recruiting
Gosford Hospital
Gosford, New South Wales, 02250
- Recruiting
Austin Health
Heidelberg, Heidelberg, 3084
- Recruiting
Joondalup Health Campus
Joondalup, Western Australia, 6027
- Recruiting
Nepean Cancer & Wellness Ctr
Kingswood, New South Wales, 2747
- Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Italy7 sites, 7 recruiting
- Recruiting
AOU Sant Orsola Malpighi
Bologna, BO, 40138
- Recruiting
Irst Meldola
Meldola, FC, 47014
- Recruiting
European Institute of Oncology
Milan, MI, 20141
- Recruiting
Humanitas San Pio X
Milan, MI, 20159
- Recruiting
IRCCS San Gerardo Tintori
Monza, MB, 20900
- Recruiting
Ospedale S Stefano
Prato, PO, 59100
- Recruiting
AUSL IRCCS Reggio Emilia
Reggio Emilia, RE, 42123
Belgium6 sites, 6 recruiting
- Recruiting
Saint-Luc University Clinics
Brussels, Brussels Capital, 1200
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
- Recruiting
Grand Hôpital de Charleroi
Gilly, Hainaut, 6060
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, Flanders, 3000
- Recruiting
CHU UCL Namur/Ste Elisabeth
Namur, Wallonia, 5000
- Recruiting
VITAZ
Sint-Niklaas, Sint-Niklaas, 9100
Israel6 sites, 6 recruiting
- Recruiting
Assuta Ashdod Hospital
Ashdod, Southern Israel, 7747629
- Recruiting
Rambam Medical Center
Haifa, Haifa District, 3109601
- Recruiting
CARMEL
Haifa, Haifa District, 3436212
- Recruiting
Wolfson Medical Center
Holon, Holon, 58110
- Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102
- Recruiting
Galilee Medical Center
Nahariya, Nahariya, 2210001
Poland6 sites, 6 recruiting
- Recruiting
Białystok Onc. Ctr. (MSC), GO
Bialystok, Podlaskie Voivodeship, 15-027
- Recruiting
ŚCO SPZOZ Kielce
Kielce, 25-734
- Recruiting
ICZMP
Lodz, Łódź Voivodeship, 93-338
- Recruiting
Centrum Onkologi Ziemi Lubelsk
Lublin, Lublin Voivodeship, 20-090
- Recruiting
Siedleckie Centrum Onkologii
Siedlce, Masovian Voivodeship, 08-110
- Recruiting
UCH No. 2, PMU Szczecin
Szczecin, West Pomeranian Voivodeship, 70-111
Germany5 sites, 5 recruiting
- Recruiting
Helios Hospital Berlin-Buch
Berlin, State of Berlin, 13125
- Recruiting
Bonn University Hospital
Bonn, North Rhine-Westphalia, 53127
- Recruiting
Asklepios Hospital Barmbek
Hamburg, Free and Hanseatic City of Hamburg, 22453
- Recruiting
Klinikum Lippe GmbH Pharmacy
Lemgo, North Rhine-Westphalia, 32657
- Recruiting
Central Whse (Zentrallager)
Wiesbaden, Hesse (Hessen), 65199
Brazil4 sites, 4 recruiting
- Recruiting
Futtura Oncologia - Hub Pesq
Porto Alegre, Rio Grande do Sul, 90470-340
- Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
- Recruiting
Oncoclinicas RJ S.A.
Rio de Janeiro, Rio de Janeiro, 2250-905
- Recruiting
Hospital Nove de Julho
São Paulo, São Paulo, 01308-070
Finland4 sites, 4 recruiting
- Recruiting
Hus Ccc/Ctu
Helsinki, Helsinki, 00250
- Recruiting
Kuopio Univ. Hospital, PSHVA
Kuopio, Northern Savonia, 70210
- Recruiting
Oulu University Hospital
Oulu, North Ostrobothnia, 90220
- Recruiting
Tampere University Hospital
Tampere, Pirkanmaa, 33520
Canada3 sites, 3 recruiting
- Recruiting
Arthur J E Child Cancer Comp
Calgary, Alberta, T2N 5G2
- Recruiting
MUHC - Glen Site
Montreal, Quebec, H4A 3J1
- Recruiting
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6
Greece3 sites, 3 recruiting
- Recruiting
Aretaieio Hospital
Athens, 115 28
- Recruiting
Alexandra General Hospital
Athens, 11528
- Recruiting
UGH Patras
Pátrai, RIO, 265 04
Lithuania2 sites, 2 recruiting
- Recruiting
LSMU Hospital Kauno klinikos
Kaunas, Central Lithuania, LT-45434
- Recruiting
Dept., VUH Santaros Clinics
Vilnius, Vilnius County, LT-08406
Norway2 sites, 2 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Vestland, NO-5021
- Recruiting
OUH Radium Hospital
Oslo, Oslofjord, 0379
Singapore2 sites, 2 recruiting
- Recruiting
NUH Singapore
Singapore, Singapore, 119082
- Recruiting
Curie Oncology (Farrer)
Singapore, Singapore, 217562
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Puerto Rico1 site, 1 recruiting
- Recruiting
PR Cancer Specialists
San Juan, 00917
About this study
Official title: A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study.
The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected.
All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).
Read the detailed description
This is a global, open-label, randomized Phase 3 study in approximately 660 participants with recurrent or progressive EC following prior therapy.
Participants will be randomized in a 1:1 ratio to receive treatment with Rina-S vs investigator's choice (IC) (paclitaxel or doxorubicin). Investigators must select one of the IC treatment options for each participant prior to randomization so that this may be used for treatment assignment if the participant is randomized to the IC arm.
- Being tested
- Rina-S, IC
- Medical subject headings
- Endometrial Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rina-SDrug
Also called Rinatabart Sesutecan, PRO1184, GEN1184
Intravenous (IV) infusion.
ICDrug
- Paclitaxel: IV infusion
- Doxorubicin: IV bolus injection/infusion
| Study group | Role | What they receive |
|---|---|---|
| Rina-S | Experimental | Participants will receive Rina-S on Day 1 once every 3 weeks (Q3W). Receives: Drug: Rina-S |
| IC | Active comparator | Participants 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. Receives: Drug: IC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)
Measured: Up to approximately 3 years
Overall Survival (OS)
Measured: Up to approximately 3 years
Secondary outcomes (8)
Objective Response Rate (ORR), per RECIST v1.1, as Determined by BICR
Measured: Up to approximately 3 years
PFS, per RECIST v1.1, as Determined by Investigator Assessment
Measured: Up to approximately 3 years
ORR, per RECIST v1.1, as Determined by Investigator Assessment
Measured: Up to approximately 3 years
Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment
Measured: Up to approximately 3 years
DOR, per RECIST v1.1, as Determined by BICR
Measured: Up to approximately 3 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 3 years
Change from Baseline in Global Health Status/Quality of Life (GHS/Qol)
Measured: Baseline up to approximately 3 years
Time to Deterioration (TTD) in GHS/Qol
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start28 Nov 2025
- Primary completionAug 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166094
- Sponsor's protocol ID
- GCT1184-03
- Other IDs
- jRCT2031250494, MOH_2026-03-29_015739, 2024-519818-31, GOG-3128, ENGOT-en31, GEICO-158-E
- Acronym
- RAINFOL-03
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No