Clinical Trials Register

Summary
EudraCT Number:	2022-002840-29
Sponsor's Protocol Code Number:	D7986C00001
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:	2023-01-16
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

2022-002840-29

A.3

Full title of the trial

A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Protocolo abierto, multifármaco, multicéntrico, de fase II para evaluar la eficacia, seguridad, tolerabilidad, farmacocinética e inmunogenicidad de nuevas combinaciones en pacientes con adenocarcinoma gástrico o gastroesofágico localmente avanzado no resecable o metastásico

A.3.1

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

Master protocol of novel combinations in participants with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Protocolo de nuevas combinaciones en pacientes con adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado no resecable o metastásico

A.4.1

Sponsor's protocol code number

D7986C00001

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Unidad de Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	C/Serrano Galvache, 56; Parque Norte, Edificio Álamo
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28033
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34900200444
B.5.6	E-mail	informacionEECC-Spain@astrazeneca.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	AZD2936
D.3.2	Product code	AZD2936
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AZD2936
D.3.9.1	CAS number	2640305-01-5
D.3.9.2	Current sponsor code	AZD2936
D.3.9.3	Other descriptive name	Monovalent bispecific humanized IgG1 antibody
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	50
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	MEDI5752
D.3.2	Product code	MEDI5752
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MEDI5752
D.3.9.2	Current sponsor code	MEDI5752
D.3.9.3	Other descriptive name	Human IgG1 monoclonal antibody with an engineered Fc domain targeting PD-1 and CTLA-4
D.3.9.4	EV Substance Code	SUB272413
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	50
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.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

Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Adenocarcinoma de la unión gastroesofágica localmente avanzado no resecable o metastásico.

E.1.1.1

Medical condition in easily understood language

Specific type of Gastric or Gastroesophageal Junction cancer which is not removable by surgery

Tipo específico de cáncer gástrico o de la unión gastroesofágica que no se puede extirpar mediante cirugía.

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	PT
E.1.2	Classification code	10001150
E.1.2	Term	Adenocarcinoma gastric
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10066354
E.1.2	Term	Adenocarcinoma of the gastroesophageal junction
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the efficacy of novel agent plus chemotherapy by evaluation of ORR (objective response rate) and PFS6 (proportion of participants alive and progression-free at 6 months)

Evaluar la eficacia del agente nuevo más quimioterapia mediante la evaluación de la TRG (tasa de respuesta objetiva) y la SLP6 (proporción de participantes vivos y libres de progresión a los 6 meses).

E.2.2

Secondary objectives of the trial

To evaluate the DoR (Duration of response), PFS (progression free survival), OS (overall survival), safety and tolerability, PK and immunogenicity of novel agent plus chemotherapy

Evaluar el DoR (duración de la respuesta), la SLP (supervivencia libre de progresión), la SG (supervivencia global), la seguridad y la tolerabilidad, la farmacocinética y la inmunogenicidad del nuevo agente más quimioterapia.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Substudy 1: MEDI5752 plus XELOX (capecitabine and oxaliplatin) or FOLFOX (5-fluorouracil, oxaliplatin, and leucovorin)
Version 1: 15 Aug 2022
Objectives: Please refer to the E.2.1 Main objective of the trial and E.2.2 secondary objectives of the trial.

Substudy 2: AZD2936 plus XELOX or FOLFOX
Version 1: 15 Aug 2022
Objectives: Please refer to the E.2.1 Main objective of the trial and E.2.2 secondary objectives of the trial.

Subestudio 1: MEDI5752 más XELOX (capecitabina y oxaliplatino) o FOLFOX (5-fluorouracilo, oxaliplatino y leucovorina)
Versión 1: 15 Aug 2022
Objetivos: Consulte el E.2.1 Objetivo principal del Protocolo y E.2.2 Objetivos secundarios del Protocolo.

Subestudio 2: AZD2936 más XELOX o FOLFOX
Versión 1: 15 Aug 2022
Objetivos: Consulte el E.2.1 Objetivo principal del protocolo y E.2.2 Objetivos secundarios del protocolo.

E.3

Principal inclusion criteria

• 18 years or older at the time of signing the ICF.
• Body weight > 35 kg.
• Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
• Has measurable target disease assessed by the Investigator based on RECIST 1.1.
• ECOG PS 0 or 1.
• Life expectancy of at least 12 weeks.
• Adequate organ and bone marrow function.

• 18 años o más en el momento de firmar el ICF.
• Peso corporal > 35 kg.
• No se ha tratado previamente para el adenocarcinoma gástrico o de la unión gastroesofágica no resecable o metastásico.
• Tener una lesión diana medible evaluada por el investigador basada en RECIST 1.1.
• ECOG PS 0 o 1.
• Esperanza de vida de al menos 12 semanas.
• Función adecuada de órganos y médula ósea.

E.4

Principal exclusion criteria

• Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by ISH] or indeterminate gastric or GEJ carcinoma.
• Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
• Participants with ascites which cannot be controlled with appropriate interventions.
• Active infectious diseases, including tuberculosis, HIV infection, or hepatitis A/B/C.
• Uncontrolled intercurrent illness.
• Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
• History of another primary malignancy.
• Previous treatment with an immune-oncology agent.

• Participantes con HER2 positivo (3+ por IHC, o 2+ por IHC y positivo por ISH) o carcinoma gástrico o GEJ indeterminado.
• Enfermedad metastásica del SNC progresiva o no tratada, cualquier enfermedad leptomeníngea o compresión medular
• Participantes con ascitis que no se puede controlar con intervenciones apropiadas.
• Enfermedades infecciosas activas, como tuberculosis, infección por VIH o hepatitis A/B/C.
• Enfermedad intercurrente no controlada.
• Trastornos autoinmunes o inflamatorios activos o documentados previamente que requieren tratamiento sistémico con esteroides u otro tratamiento inmunosupresor.
• Antecedentes de otra neoplasia maligna primaria.
• Tratamiento previo con un agente inmuno-oncológico.

E.5 End points

E.5.1

Primary end point(s)

ORR in response evaluable set

PFS6 in full analysis set

TRO (Tasa Respuesta Objetiva) en respuesta conjunto evaluable.

SLP6 en conjunto de análisis completo.

E.5.1.1

Timepoint(s) of evaluation of this end point

At a minimum of 6 months following the last participant’s first dose in the substudy

Al menos 6 meses después de la primera dosis del último participante en el subestudio.

E.5.2

Secondary end point(s)

• DoR per RECIST 1.1 based on Investigator assessment.
• PFS per RECIST 1.1 as assessed by the Investigator.
• OS.
• Incidence of AEs, AESIs, and SAEs; physical examination; Laboratory findings; vital signs; 12-lead ECG.
• Serum concentrations of novel agent and derived PK parameters.
• Incidences of ADAs against novel agent in serum.

• DoR por RECIST 1.1 basado en la evaluación del investigador.
• SLP según RECIST 1.1 según lo evaluado por el investigador.
•Supervivencia Global.
• Incidencia de EAs, AESIs, y SAEs; examen físico; Hallazgos de laboratorio; signos vitales; ECG de 12 derivaciones.
• Concentraciones séricas de nuevos agentes y parámetros farmacocinéticos derivados.
• Incidencias de ADAs (Anticuerpos anti Droga) contra agente novedoso en suero.

E.5.2.1

Timepoint(s) of evaluation of this end point

Until end of study

Hasta el final del estudio.

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

Yes

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

Yes

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

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

China

Japan

Korea, Republic of

Taiwan

United States

Spain

United Kingdom

E.8.7

Trial has a data monitoring committee

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 end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the SoA for the last participant in the study globally.

El final del estudio se define como la fecha de la última visita del último participante en el estudio o el último procedimiento programado que se muestra en la ToA (tabla de Actividades) para el último participante en el estudio a nivel global.

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

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)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

F.4.2.2

In the whole clinical trial

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)

Participants who continue to demonstrate clinical benefit after the protocol specified 24-month treatment period will be eligible to receive study intervention, via a roll-over study or safety extension study requiring approval by the responsible Health Authority and ethics committee or following discussion with and approval from the AstraZeneca Study Team.

Los participantes que continúen demostrando beneficios clínicos después del período de tratamiento de 24 meses especificado por el protocolo serán elegibles para recibir la intervención del estudio, a través de un estudio de renovación o un estudio de extensión de seguridad que requiera la aprobación de la Autoridad Sanitaria responsable y el comité de ética o después de la discusión y aprobación del Equipo de Estudio de AstraZeneca.

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

2023-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-01-12

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

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