A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL (EPCORE DLBCL-1)

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT

Study Overview

• Status: Active, not recruiting
• Conditions: Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Biological: Epcoritamab; Drug: Investigator's Choice Chemotherapy

Detailed Description

The trial is an open label, multi-center, global phase 3 randomized trial of epcoritamab, GEN3013. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in patients with relapsed, refractory diffuse large B-Cell Lymphoma who have failed or are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). No change in chemotherapy is permitted for participants during the treatment phase of the trial.

• Study Type: Interventional
• Enrollment (Estimated): 552
• Phase: Phase 3

Expanded Access

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Contacts and Locations

Study Locations

• Australia
  • Bedford Park, Australia
    • Flinders Medical Centre
  • Concord, Australia
    • Concord Repatriation General Hospital
  • Frankston, Australia
    • Peninsula Private Hospital Clinical Trials Unit
  • South Brisbane, Australia
    • Icon Cancer Centre Corporate Office
  • Waratah, Australia
    • Calvary Mater Newcastle
  • Westmead, Australia
    • Westmead Hospital
• Austria
  • Linz, Austria
    • Ordensklinikum Linz Barmherzige Schwestern
  • Linz, Austria
    • Ordensklinikum Linz Gmbh Elisabethinen
  • Salzburg, Austria
    • Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU
• Belgium
  • Antwerp, Belgium
    • ZNA Middelheim
  • Brugge, Belgium
    • AZ Sint-Jan
  • Brussels, Belgium
    • Institut Jules Bordet
  • Gent, Belgium
    • Universitair Ziekenhuis Gent
  • Jette, Belgium
    • UZ Brussel
  • La Louvière, Belgium
    • Hôpital de Jolimont
  • Leuven, Belgium
    • Universitair Ziekenhuis gasthuisberg Leuven
  • Sint-Niklaas, Belgium
    • AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme
  • Turnhout, Belgium
    • AZ Turnhout, Campus Sint-Elisabeth
• Canada
  • Québec City, Canada
    • CHU de Quebec-Universite Laval
• China
  • Baoding, China
    • Affiliated Hospital of Hebei University
  • Beijing, China
    • Beijing Cancer Hospital
  • Beijing, China
    • Beijing Tongren Hospital, Capital Medical University
  • Changchun, China
    • the First Hospital of Jilin University
  • Chengdu, China
    • West China Hospital, Sichuan University
  • Dalian, China
    • The Second Hospital of Dalian Medical University
  • Guangdong, China
    • Guangdong Provincial Peoples Hospital
  • Guangxi, China
    • Guangxi Medical University Affiliated Tumor Hospital
  • Hangzhou, China
    • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Hubei, China
    • Hubei Cancer Hospital
  • Hunan, China
    • Hunan Cancer Hospital
  • Nanchang, China
    • The First Affiliated Hospital of Nanchang University
  • Qingdao, China
    • Qingdao Central Hospital
  • Shanxi, China
    • Shanxi Provincial Cancer Hospital
  • Shenyang, China
    • Shengjing Hospital Of China Medical University
  • Shenzhen, China
    • Shenzhen Peoples Hospital
  • Suzhou, China
    • The First Affiliated Hospital Of Soochow University
  • Tianjin, China
    • Tianjin Medical University Cancer Institute and Hospital
  • Wuhan, China
    • EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Yantai, China
    • Yantai Yuhuangding Hospital
  • Zhengzhou, China
    • Henan Cancer Hospital
  • Zhenjiang, China
    • The Second Affiliated Hospital Zhejiang University School of Medicine
• Denmark
  • Aalborg, Denmark
    • Aalborg Universitetshospital
  • Aarhus, Denmark
    • Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116
  • Roskilde, Denmark
    • Clinical Research Unit, Roskilde Sygehus
  • Vejle, Denmark
    • Vejle Hospital
• Finland
  • Helsinki, Finland
    • HUS Cancer Center/ Clinical Trial Unit
  • Oulu, Finland
    • Oulu university hospital, Department of hematology
• France
  • Amiens, France
    • Audrey ALEME
  • Bayonne, France
    • Centre Hospitalier de la Cote Basque
  • Brest, France
    • CHRU de Brest - Hospital Morvan
  • Caen, France
    • CHU Caen - IHBN
  • La Rochelle, France
    • Groupe Hospitalier de La Rochelle
  • Limoges, France
    • Chu de Limoges
  • Lyon, France
    • Centre Leon Berard
  • Marseille, France
    • Hopital de la Conception APHM
  • Nantes, France
    • CHU de Nantes - Hotel Dieu
  • Nice, France
    • Centre Antoine Lacassagne
  • Paris, France
    • Hopital Saint-Louis
  • Paris, France
    • Clinique Victor Hugo
  • Pessac, France
    • CHU de Bordeaux Hôpital Haut-Lévêque
  • Pierre-Bénite, France
    • Centre Hospitalier Lyon Sud
  • Poitiers, France
    • CHU de Poitiers - Hôpital la Milétrie
  • Pontoise, France
    • Centre Hospitalier Rene Dubos
  • Quimper, France
    • Ch Cornouaille
  • Rouen, France
    • Centre Henri Becquerel
  • Tours, France
    • CHRU Tours Hopital Bretonneau
• Germany
  • Cologne, Germany
    • Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094
  • Essen, Germany
    • Universitaetsklinikum Essen
  • Kiel, Germany
    • Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie
  • Würzburg, Germany
    • Universitätsklinikum Würzburg
• Hungary
  • Budapest, Hungary
    • National Institute of Oncology
  • Budapest, Hungary
    • Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika
  • Debrecen, Hungary
    • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia
  • Eger, Hungary
    • Belgyógyászati osztály Markhot Ferenc Kórház
  • Győr, Hungary
    • Petz Aladar Egyetemi Oktato Korhaz
  • Nyiregyhaza, Hungary
    • Josa Andras Teaching Hospital, Hematology Dept
  • Pécs, Hungary
    • University of Pecs 1st. Internal medicine Clinic Dept. Hematology
  • Szeged, Hungary
    • Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia
  • Szekesfehervar, Hungary
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• Israel
  • Haifa, Israel
    • Bnai Zion Medical Center
  • Haifa, Israel
    • Rambam Health Care Center
  • Jerusalem, Israel
    • Shaare Zedek Medical Center
  • Jerusalem, Israel
    • Hadassah University Hospital
  • Tel Aviv, Israel
    • Sourasky Medical Center
• Italy
  • Bari, Italy
    • IRCCS Istituto Tumori Giovanni Paolo II Bari
  • Bergamo, Italy
    • Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi)
  • Brescia, Italy
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Meldola, Italy
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
  • Milan, Italy
    • San Raffaele Hospital
  • Milan, Italy
    • Istituto Oncologico Europeo
  • Novara, Italy
    • Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C
  • Ravenna, Italy
    • Ospedale Santa Maria delle Croci
  • Rome, Italy
    • Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra
  • San Giovanni Rotondo, Italy
    • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Trieste, Italy
    • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste
  • Venezia, Italy
    • SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo
• Japan
  • Fukuoka, Japan
    • Kyushu University Hospital
  • Fukushima, Japan
    • Fukushima Medical University Hospital
  • Fukuyama, Japan
    • Chugoku Central Hospital
  • Hokkaido, Japan
    • Hokkaido University Hospital
  • Kashiwa, Japan
    • National Cancer Center Hospital East
  • Kyoto, Japan
    • Kyoto University Medical Hospital
  • Matsuyama, Japan
    • Matsuyama Red Cross Hospital
  • Mie, Japan
    • Mie University Hospital
  • Nagoya, Japan
    • Japanese Red Cross Nagoya Daini Hospital
  • Nagoya, Japan
    • NHO Nagoya Medical Center
  • Okayama, Japan
    • Okayama University Hospital
  • Sendai, Japan
    • Tohoku University Hospital
  • Tokyo, Japan
    • Keio University Hospital
  • Tokyo, Japan
    • National Cancer Center Hospital
  • Tokyo, Japan
    • Tokai University Hospital
  • Toyoake, Japan
    • Fujita Health University Hospital
  • Yamagata, Japan
    • Yamagata University Hospital
  • Ōsaka-sayama, Japan
    • Kindai University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong-A University Hospital
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Busan, Korea, Republic of
    • Pusan National University Hosptial
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Hospital
  • Geumam, Korea, Republic of
    • Chonbuk National University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
• Netherlands
  • Arnhem, Netherlands
    • Rijnstate Arnhem
  • Breda, Netherlands
    • Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43
  • Dordrecht, Netherlands
    • Albert Schweitzer Ziekenhuis
  • Goes, Netherlands
    • Admiraal de Ruyter Ziekenhuis
  • Roosendaal, Netherlands
    • Bravis Ziekenhuis
  • Rotterdam, Netherlands
    • Erasmus MC
  • Rotterdam, Netherlands
    • Franciscus Gasthuis And Vlietland
• Norway
  • Oslo, Norway
    • Oslo University Hospital location Radium hospital
  • Trondheim, Norway
    • St. Olavs Hospital HF
• Poland
  • Katowice, Poland
    • Pratia Onkologia Katowice
  • Kraków, Poland
    • Pratia MCM Krakow
  • Skorzewo, Poland
    • Centrum Medyczne Pratia Poznan
  • Wrocław, Poland
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Łódź, Poland
    • Instytut Centrum Zdrowia Matki Polki
  • Łódź, Poland
    • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
• Russian Federation
  • Kazan, Russian Federation
    • State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr
  • Leningrad, Russian Federation
    • State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital
  • Moscow, Russian Federation
    • Federal State Budgetary Institution
  • Moscow, Russian Federation
    • Federal State Budgetary Institution of Science
  • Nizhny Novgorod, Russian Federation
    • State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl
  • Saint Petersburg, Russian Federation
    • Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of
• Singapore
  • Kent Ridge, Singapore
    • National University Hospital
  • Singapore, Singapore
    • National Cancer Centre Singapore
  • Singapore, Singapore
    • Clinical Trials and Research Centre
• Spain
  • Badalona, Spain
    • ICO Badalona - Hospital Universitari Germans Trias i Pujol
  • Barcelona, Spain
    • ICO l'Hospitalet - Hospital Duran i Reynals
  • Cadiz, Spain
    • Hospita Universitario Puerta Del Mar
  • Cáceres, Spain
    • Hospital San Pedro de Alcántara
  • Cáceres,, Spain
    • Hospital San Pedro de Alcántara
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
  • Lleida, Spain
    • Hospital Arnau de Vilanova
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain
    • MD Anderson Cancer Center
  • Salamanca, Spain
    • Hospital Universitario de Salamanca
  • Santander, Spain
    • Hospital Universitario Marques de Valdecilla
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocio
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain
    • Hospital Universitario Virgen De Valme
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital
• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • Tri-Service General Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
• Turkey
  • Ankara, Turkey
    • Ankara University Medical Faculty
  • Ankara, Turkey
    • Gazi University Medical Faculty
  • Ankara, Turkey
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
  • Istanbul, Turkey
    • Istanbul University Medical Faculty
  • Istanbul, Turkey
    • Amerikan Hospital
  • Istanbul, Turkey
    • Iqvia Tibbi Istatistik
  • Istanbul, Turkey
    • Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi
  • Tekirdağ, Turkey
    • Tekirdag Namik Kemal University
  • Trabzon, Turkey
    • Karadeniz Technical University
  • İzmir, Turkey
    • Ege University Medical Faculty
  • İzmir, Turkey
    • Dokuz Eylul University Medical Faculty
• United Kingdom
  • Birmingham, United Kingdom
    • Haematology - University Hospitals Birmingham NHS Foundation Trust
  • London, United Kingdom
    • Hammersmith Hospital
  • London, United Kingdom
    • Guys and St Thomas Nhs Foundation Trust
  • Norwich, United Kingdom
    • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • Nottingham, United Kingdom
    • Nottingham University Hospitals NHS Trust
  • Plymouth, United Kingdom
    • Derriford Hospital
  • Southampton, United Kingdom
    • University Hospital Southampton
  • Sutton, United Kingdom
    • Royal Marsden NHS Foundation Trust (Sutton)
  • Truro, United Kingdom
    • Royal Cornwall Hospital
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indiana Blood and Marrow Transplantation
    • Indianapolis, Indiana, United States, 46250
      • Community Health Network Cancer Center North
  • Michigan
    • Jackson, Michigan, United States, 49201
      • Henry Ford Health System
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45247
      • TriHealth Cancer Institute- Good Samaritan Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

1. Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis

2. One of the confirmed histologies below with CD20-positivity:

   1. DLBCL, NOS, including de novo or histologically transformed from FL
   2. "Double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
   3. FL Grade 3B
   4. T-cell/histiocyte-rich large B-cell lymphoma
3. ECOG PS score of 0-2
4. Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
5. Patients must have detectable disease by PET scan and measurable by CT scan or MRI
6. Acceptable renal and liver function
7. Life expectancy >2 months on SOC treatment

Main Exclusion Criteria:

1. Primary Central Nervous System (CNS) tumor or known CNS involvement
2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
3. Major surgery within 4 weeks prior to randomization
4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
6. ASCT within 100 days of randomization
7. Treatment with CAR-T therapy within 100 days prior to randomization
8. Seizure disorder requiring anti-epileptic therapy
9. Clinically significant cardiac disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epcoritamab (GEN3013; DuoBody®CD3xCD20); Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met	Biological: Epcoritamab; Following mandatory pre-medication subject will be administered epcoritamab as a subcutaneous injection.; Other Names: GEN3013; DuoBody®-CD3xCD20; EPKINLY™
Active Comparator: Investigator's choice of chemotherapy; R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met	Drug: Investigator's Choice Chemotherapy; Following mandatory pre-medication subject will be administered intravenously either BR or R-GemOx.; Other Names: BR or R-GemOx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is calculated as the time from first dose to death date or last date known to be alive.	throughout the study and up to 5 years following the last patient first dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS is calculated as the time from randomization to the date of disease progression or death, whichever is earlier. Progression is determined by the Lugano criteria and LYRIC.	throughout the study and up to 5 years following the last patient first dose
Overall Response Rate (ORR)	ORR is calculated as the proportion of subjects achieving a complete response or partial response. Response is determined by the Lugano criteria and LYRIC.	throughout the study and up to 5 years following the last patient first dose
Complete Response (CR)	CR rate is calculated as the proportion of subjects achieving a complete response. Response is determined by the Lugano criteria and LYRIC.	throughout the study and up to 5 years following the last patient first dose
Duration of Response (DOR)	DOR is calculated as the time from initial response (CR or PR) to date of progression or death, whichever is earlier. Response and progression are determined by the Lugano criteria and LYRIC.	throughout the study and up to 5 years following the last patient first dose
Time to Response (TTR)	TTR is calculated as the time from randomization to date of initial response (CR or PR) among responders only. Response is determined by the Lugano criteria and LYRIC.	throughout the study and up to 5 years following the last patient first dose
Rate and duration of minimal residual disease (MRD) negative status	Compare other measures of efficacy to SOC - MRD negativity rate, defined as the proportion of subjects who have at least one negative MRD sample at any time point prior to start of subsequent anti-lymphoma therapy	up to 5 years after randomization of the last patient
Time to next anti-lymphoma therapy (TTNT)	TTNT is calculated as the time from randomization to date of initiation of new anti-lymphoma therapy.	throughout the study and up to 5 years following the last patient first dose
Incidence and severity of adverse events (AEs)	identify patterns of incidence in adverse events, with particular emphasis on pre-defined adverse events of special interest	throughout the study and up to 5 years following the last patient first dose
Incidence and severity of changes in laboratory values	Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, immunoglobulins, and urinalyses	throughout the study and up to 5 years following the last patient first dose
Incidence of dose interruptions and delays	calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall	throughout the study and up to 5 years following the last patient first dose
Anti-epcoritamab antibody response	calculate incidence of antibody response to epcoritamab in relation to dosing	throughout the study and up to 5 years following the last patient first dose
Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)	monitor change from baseline in health-related quality of life over time and in relation to treatment	throughout the study and up to 5 years following the last patient first dose

Collaborators and Investigators

• Sponsor: Genmab
• Collaborators: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: double-hit DLBCL; triple-hit DLBCL; follicular grade 3B; transformed DLBCL; T-cell histiocytes-rich large B cell lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: GCT3013-05; 2020-003016-27 (EudraCT Number); jRCT2021220017 (Registry Identifier: Japan Registry for Clinical Trials (jRCT)); CTR20221558 (Registry Identifier: Drug Clinal Trial Registration and Information Disclosure Platform (ChinaDrugTrials.org.cn)); MOH_2021-01-18_009672 (Registry Identifier: Clinical Research Site - mytrial); 286972 (Other Identifier: IRAS ID; UK Research Summaries Database); 2023-504830-23-00 (Ctis: EU CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No