Clinical Trials Register

Summary
EudraCT Number:	2021-005744-29
Sponsor's Protocol Code Number:	GCT3013-06
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-08-10
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-005744-29

A.3

Full title of the trial

A RANDOMIZED, OPEN-LABEL, MULTICENTER, GLOBAL, PHASE 2 TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF EPCORITAMAB (GEN3013; DUOBODY®-CD3×CD20) AS MONOTHERAPY OR IN COMBINATION WITH LENALIDOMIDE AS FIRST-LINE THERAPY FOR ANTHRACYCLINE-INELIGIBLE SUBJECTS WITH DIFFUSE LARGE B CELL LYMPHOMA

ENSAYO GLOBAL DE FASE II, MULTICÉNTRICO, ALEATORIZADO Y ABIERTO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE EPCORITAMAB (GEN3013; DUOBODY®-CD3×CD20) COMO MONOTERAPIA O EN COMBINACIÓN CON LENALIDOMIDA COMO TRATAMIENTO DE PRIMERA LÍNEA PARA SUJETOS CON LINFOMA DIFUSO DE CÉLULAS B GRANDES NO APTOS PARA TRATAMIENTO CON ANTRACICLINAS

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

EFFICACY AND SAFETY TRIAL OF EPCORITAMAB WITH OR WITHOUT LENALIDOMIDE AS FIRST LINE THERAPY FOR SUBJECTS WITH DIFFUSE LARGE B-CELL LYMPHOMA

ENSAYO DE EFICACIA Y SEGURIDAD DEL EPCORITAMAB CON O SIN LENALIDOMIDA COMO TRATAMIENTO DE PRIMERA LÍNEA PARA SUJETOS CON LINFOMA DIFUSO DE CÉLULAS B GRANDES

A.3.2

Name or abbreviated title of the trial where available

EPCORE™ DLBCL-3

A.4.1

Sponsor's protocol code number

GCT3013-06

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Genmab A/S
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Genmab A/S
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Genmab US, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Genmab A/S
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Kalvebod Brygge 43
B.5.3.2	Town/ city	Copenhagen V
B.5.3.3	Post code	DK-1560
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+349155048003750
B.5.6	E-mail	clinicaltrials@genmab.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Epcoritamab
D.3.2	Product code	GEN3013
D.3.4	Pharmaceutical form	Concentrate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Epcoritamab
D.3.9.1	CAS number	2134641-34-0
D.3.9.3	Other descriptive name	GEN3013 (DuoBody®-CD3xCD20)
D.3.9.4	EV Substance Code	SUB190479
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Epcoritamab
D.3.2	Product code	GEN3013
D.3.4	Pharmaceutical form	Concentrate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Epcoritamab
D.3.9.1	CAS number	2134641-34-0
D.3.9.3	Other descriptive name	GEN3013 (DuoBody®-CD3xCD20)
D.3.9.4	EV Substance Code	SUB190479
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lenalidomide
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenalidomide
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lenalidomide
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenalidomide
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

B-cell Lymphoma

Linfoma de linfocitos B

E.1.1.1

Medical condition in easily understood language

Lymphoma of B-cell origin

Linfoma de origen de células B

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10012819
E.1.2	Term	Diffuse large B-cell lymphomas
E.1.2	System Organ Class	100000004851

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomide

Evaluar la eficacia clínica del epcoritamab en monoterapia o del epcoritamab y la lenalidomida

E.2.2

Secondary objectives of the trial

1. Evaluate other efficacy measures of epcoritamab monotherapy or epcoritamab and lenalidomide
2. Evaluate safety and tolerability of epcoritamab monotherapy or epcoritamab and lenalidomide
3. Evaluate immunogenicity
4. Assess the pharmacokinetics of epcoritamab
5. Evaluate patient-reported outcomes related to lymphoma symptoms

1. Evaluar otras medidas de la eficacia del epcoritamab en monoterapia o del epcoritamab y la lenalidomida
2. Evaluar la seguridad y la tolerabilidad del epcoritamab en monoterapia o del epcoritamab y la lenalidomida
3. Evaluar la inmunogenia
4. Evaluar la farmacocinética del epcoritamab
5. Evaluar los resultados comunicados por el paciente relacionados con los síntomas del linfoma

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Must have newly diagnosed CD20+ large cell lymphoma limited to the following histologies (according to the World Health Organization [WHO] 2016 classification).
•Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to:
oBeing age ≥80 years; AND/OR
oBeing age ≥75 years and having important comorbid condition(s), which are likely to have a negative impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy, Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of 10.
•Have Ann Arbor Stage II-IV disease.
•Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to ≤2 prior to enrollment.)
•Have measurable disease as per Lugano criteria.
•Have acceptable organ function based on baseline bloodwork.
•Must have fresh (preferred) or archival biopsy material at screening.

• Se le debe haber diagnosticado recientemente el linfoma de linfocitos grandes mediante un resultado positivo de CD20 limitado a las siguientes histologías (según la clasificación de la Organización Mundial de la Salud [OMS] de 2016).
•No es apto para la quimioterapia que contiene una antraciclina o la quimioterapia citotóxica debido a:
• que tiene >80 años; o
• que tiene >75 años y enfermedades concomitantes importantes que podrían tener un impacto negativo en la tolerabilidad de la quimioterapia que contiene una antraciclina o la quimioterapia citotóxica, tiene una puntuación en la escala de encefalopatía asociada a células efectoras inmunes (escala ICE) de al menos 8 sobre 10.
•Presenta una enfermedad en estadio II-IV según la clasificación Ann Arbor.
•Tener un EG según el ECOG de 0, 1 o 2; (se puede considerar un EG según el ECOG de 3 si el deterioro se atribuye al linfoma/LDCBG actual y si el tratamiento previo durante la fase de selección da lugar a una mejora del EG según el ECOG a <2 antes de la inclusión).
•Presenta enfermedad medible según los criterios de Lugano.
•Presenta una función orgánica aceptable según los análisis de sangre iniciales.
•Debe tener material de biopsia en fresco (preferible) o de archivo en el momento de la selección.

E.4

Principal exclusion criteria

•Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection.
•Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy),
•Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes:
oMajor surgery within 4 weeks prior to the first dose of epcoritamab;
oNon-investigational antineoplastic agents (except anti-CD20 monoclonal antibodies) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab;
oAutologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation;
oLive, attenuated vaccines within 30 days prior to initiation of epcoritamab;
oInvestigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed);
oInvasive investigational medical device use within 28 days before the planned first dose of epcoritamab.
•Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumbar puncture.
•Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form.
•Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol.
•Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS).
•Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]-positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis.
•Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment.
•Has suspected active or inadequately treated latent tuberculosis.
•Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards.

• Tiene una infección activa bacteriana, vírica, fúngica, microbacteriana, parasitaria o de otro tipo en el momento de la inclusión en el ensayo conocida y clínicamente significativa, incluida la infección por la covid-19.
• Tiene una enfermedad cardiovascular grave (aparte de los criterios de idoneidad que impiden que el sujeto reciba quimioterapia que contiene una antraciclina o quimioterapia citotóxica).
• Ha estado expuesto o ha recibido alguno de los siguientes tratamientos o procedimientos previos dentro de los plazos especificados: • Cirugía mayor dentro en el plazo de las 4 semanas anteriores a la primera dosis del epcoritamab. • Antineoplásicos que no estén en investigación (excepto los anticuerpos monoclonales anti-CD20) o cualquier medicamento en investigación en el plazo de las 4 semanas o 5 semividas, el que sea más corto, antes de la primera dosis del epcoritamab. • Autotransplante de hemocitoblastos (HSCT), tratamiento con linfocitos T-CAR, alotrasplante de células progenitoras o trasplante de vísceras macizas. • Vacunas con microbios vivos atenuadas en el plazo de los 30 días anteriores al inicio del epcoritamab.
• Vacunas en investigación en el plazo de los 28 días anteriores a la primera dosis prevista del epcoritamab (es decir, no se permiten las vacunas y tratamientos experimentales o no autorizados contra el SARS-CoV-2).
• Uso invasivo de un dispositivo médico en investigación en el plazo de los 28 días anteriores a la primera dosis prevista del epcoritamab.
•Tiene un tumor primario del sistema nervioso central (SNC) o una afectación conocida del SNC o una afectación intracraneal confirmadas mediante una resonancia magnética (RM) o una tomografía axial computarizada (TAC) del cerebro obligatorias en el momento de la selección y, si está clínicamente indicado, mediante una punción lumbar.
•Tiene un trastorno epiléptico que requiere tratamiento antiepiléptico o tuvo una crisis epiléptica en el plazo de los 6 meses anteriores a la firma del formulario de consentimiento informado.
Ha tenido una neoplasia maligna conocida en el pasado o tiene una en la actualidad distinta al diagnóstico para la inclusión, con excepciones según se indica en el protocolo.
•Tiene alergias, hipersensibilidad o intolerancia conocidas o sospechadas a cualquiera de los tratamientos del ensayo o existe una contraindicación conocida o sospechada para el uso de todos los tratamientos contra las citocinas disponibles localmente según las directrices locales para el tratamiento del síndrome de liberación de citocinas (SLC).
•Tiene una infección activa por el virus de la hepatitis B (VHB) (reacción en cadena de la polimerasa [PCR] positiva para el ADN) o por el virus de la hepatitis C (VHC) (PCR positiva para el ARN), abuso actual de alcohol o cirrosis.
Tiene una infección activa por citomegalovirus (CMV) (PCR positiva para el ADN) que requiere tratamiento.
•Se sospecha que tiene tuberculosis latente activa o tratada de forma inadecuada.
•Tiene antecedentes conocidos de seropositividad para el VIH. Nota: Las pruebas para el VIH son necesarias solo en la selección si lo requieren las autoridades sanitarias locales o las normas institucionales.

E.5 End points

E.5.1

Primary end point(s)

Complete response (CR) rate determined by Lugano criteria

Tasa de respuesta completa (RC) determinada por los criterios de Lugano

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to the protocol.

Por favor consulte el protocolo.

E.5.2

Secondary end point(s)

1. Duration of response (DOR) determined by Lugano criteria
2. Duration of complete response (DOCR) determined by Lugano criteria
3. Time to response (TTR) determined by Lugano criteria
4. Overall response rate (ORR) determined by Lugano criteria
5. Progression-free survival (PFS) determined by Lugano criteria
6. Time to next (anti-lymphoma) therapy (TTNT)
7. Rate and duration of minimal residual disease (MRD) negative status
8. Overall survival (OS)
9. Incidence of dose-limiting toxicities (DLTs)
10. Incidence and severity of adverse events (AEs)
11. Incidence and severity of changes in laboratory values
12. Incidence of antidrug antibodies (ADAs) to epcoritamab
13. PK parameters (clearance, volume of distribution, area under-the-concentration-time curve [AUC0-last and AUC0-∞], maximum concentration [Cmax], time of Cmax [Tmax], predose values, and half-life [t½])
14. Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)

1. Duración de la respuesta (DR) determinada por los criterios de Lugano
2. Duración de la respuesta completa (DRC) determinada por los criterios de Lugano
3. Tiempo hasta la respuesta (THR) determinado por los criterios de Lugano
4. Tasa de respuesta global (TRG) determinada por los criterios de Lugano
5. Supervivencia sin progresión (SSP) determinada por los criterios de Lugano
6. Tiempo hasta el siguiente tratamiento (contra el linfoma) (THST)
7. Tasa y duración del estado negativo de la enfermedad mínima residual (EMR)
8. Supervivencia global (SG)
9. Incidencia de toxicidades limitantes de la dosis (TLD)
10. Incidencia e intensidad de los acontecimientos adversos (AA)
11. Incidencia e intensidad de los cambios en los valores analíticos
12. Incidencia de los anticuerpos antifármaco (AAF) contra el epcoritamab
13. Parámetros FC (aclaramiento, volumen de distribución, área bajo la curva de concentración-tiempo [ABCC-últ. y ABCC-ro], concentración máxima [Cmáx], tiempo de la Cmáx [Tmáx], valores anteriores a la dosis y semivida [t1/2])
14. Cambios en los síntomas del linfoma medidos por la evaluación funcional del tratamiento del cáncer: linfoma (FACT-Lym)

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to the Protocol.

Por favor consulte el protocolo

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Tratamiento combinado

Combination therapy

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Japan

Korea, Republic of

United States

Austria

France

Poland

Spain

Czechia

Germany

Italy

Belgium

Denmark

Portugal

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The trial is considered completed when the last subject dies or withdraws from the trial. The maximum trial duration is approximately 3 years after the last subject’s first treatment in the trial.

El ensayo se considera finalizado cuando el último participante fallezca o se retire del ensayo. La duración máxima del ensayo es de aproximadamente 3 años después del primer tratamiento del último participante en el ensayo.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

105

F.4.2.2

In the whole clinical trial

180

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Ninguno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-10-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-10-05

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
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