Clinical Trials Register

Summary
EudraCT Number:	2021-005873-25
Sponsor's Protocol Code Number:	SN201
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:	2022-01-17
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

2021-005873-25

A.3

Full title of the trial

A multicentric phase 1/2 trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care treatment in patients with gastric and pancreatic adenocarcinoma

Ensayo en fase I/II multicéntrico para evaluar la seguridad y la eficacia de SOT102 en monoterapia y en combinación con el tratamiento estándar en pacientes con adenocarcinoma gástrico y pancreático

A.3.1

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

A study to evaluate the safety and efficacy of SOT102 as a single drug or in combination with standard of care treatment, in patients with stomach and pancreas cancer

Un estudio para evaluar la seguridad y eficacia de SOT102 como fármaco único o en combinación con el tratamiento estándar, en pacientes con cáncer de estómago y páncreas

A.4.1

Sponsor's protocol code number

SN201

A.5.4

Other Identifiers

Name:

IND Number

Number:

157062

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	SOTIO Biotech a.s.
B.1.3.4	Country	Czechia
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	SOTIO Biotech a.s.
B.4.2	Country	Czechia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SOTIO Biotech a.s.
B.5.2	Functional name of contact point	Clinical Trial SOTIO
B.5.3	Address:
B.5.3.1	Street Address	Jankovcova 1518/2
B.5.3.2	Town/ city	Prague 7
B.5.3.3	Post code	170 00
B.5.3.4	Country	Czechia
B.5.6	E-mail	clinicaltrial@sotio.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	SOT102
D.3.2	Product code	SOT102
D.3.4	Pharmaceutical form	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	antibody-drug conjugate of an anti-CLDN18.2 mAb and the cytotoxic drug PNU159682, coupled by a Gly2-EDA linker
D.3.9.2	Current sponsor code	SOT102
D.3.9.3	Other descriptive name	SOT102
D.3.9.4	EV Substance Code	SUB253422
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	10
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)	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	Yes
D.3.11.13.1	Other medicinal product type	– antibody-drug conjugate

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

Gastric and pancreatic adenocarcinoma

Adenocarcinoma gástrico y pancreático

E.1.1.1

Medical condition in easily understood language

Stomach and pancreas cancer

Cáncer de estómago y de páncreas

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	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	100000004864

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	10051971
E.1.2	Term	Pancreatic adenocarcinoma
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part A and Part B
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT102 given as monotherapy and in combination with first-line SoC treatment. MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT) evaluable patients experiencing a DLT. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested.
Part C and Part D
To assess the efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment by objective response rate

Parte A y Parte B
Determinar la dosis máxima tolerada (DMT) y la dosis recomendada de fase 2 (DPR) de SOT102 administrada como monoterapia y en combinación con el tratamiento de primera línea de SoC. La MTD se define como el nivel de dosis más alto probado por debajo del nivel de dosis asociado con ≥33% de los pacientes evaluables por toxicidad limitante de la dosis (DLT) que experimentan una DLT. La RP2D se seleccionará basándose en la evaluación integrada de la totalidad de los datos clínicos y preclínicos, para todos los niveles de dosis probados.
Parte C y Parte D
Evaluar la eficacia de SOT102 en monoterapia y en combinación con el tratamiento de primera línea de SoC mediante la tasa de respuesta objetiva

E.2.2

Secondary objectives of the trial

Part A and Part B
To assess the safety and tolerability of SOT102 in monotherapy and in combination with first-line SoC treatment by the occurrence of DLTs, occurrence of treatment-emergent AEs (TEAEs), SOT102-related AEs, serious AEs, AEs leading to premature discontinuation of SOT102, deaths, or clinical laboratory test abnormalities. To characterize the pharmacokinetics (PK) of total SOT102, conjugated SOT102, main metabolites.
Part C and Part D
To evaluate additional measures of efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment by duration of response, progression-free survival per RECIST 1.1, clinical benefit rate per RECIST 1.1 (Part C only), overall survival. To assess the safety and tolerability of SOT102 in monotherapy and in combination with first-line SoC treatment by the occurrence of TEAEs, SOT102-related AEs, SAEs, AEs leading to premature discontinuation of SOT102, deaths, or clinical laboratory test abnormalities

PartA y PartB
Evaluar seguridad y tolerabilidad de SOT102 en monoterapia y en combinación con el tratmto de primera línea de EoC mediante la aparición de: DLT, EA emergentes del tratmto (TEAE), EA relacionados con SOT102, EA graves, EA que conducen a interrupción prematura de SOT102, muertes o anomalías de pruebas de lab clínico.Caracterizar la farmacocinética (FC) de SOT102 total, SOT102 conjugado, principales metabolitos
PartC y PartD
Evaluar medidas adicionales de eficacia de SOT102 en monoterapia y en combinación con el tratmto de primera línea de EoC mediante la duración de respuesta, supervivencia libre de progresión según RECIST 1.1, tasa de beneficio clínico según RECIST 1.1(sólo PartC), supervivencia global. Evaluar seguridad y tolerabilidad de SOT102 en monoterapia y en combinación con el tratmto de primera línea con EoC por aparición de EAE, EA relacionados con SOT102, EAE, EAE que conduzcan a interrupción prematura de SOT102, muertes o anomalías en pruebas de lab clínico

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria applicable to all trial parts
1Age ≥18 years
2Written informed consent given prior to any trial-specific procedures
3Adequate organ function as assessed by the following parameters: hematologic; hepatic; renal; prothrombin time/international normalized ratio (INR); albumin; proteinuria.
4Eastern Cooperative Oncology Group (ECOG) performance status ≤1
5Estimated life expectancy ≥3 months as per investigator’s assessment
6A female patient is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies:
6.1Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile.
6.2A WOCBP who agrees to use a highly effective contraceptive method during the treatment period and for at least 9 months after the last dose of SOT102
7Male patients must agree to use a condom during treatment and for 9 months after SOT102 or first-line SoC treatment discontinuation
8Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiography or nuclear medicine methodology (multiple gated acquisition scanning [MUGA])
9QTcF interval <450 msec on screening electrocardiogram (ECG)
10Patient is, in the judgement of the investigator, an appropriate candidate for experimental therapy
11Patient agrees not to participate in other interventional clinical trials while enrolled in the present trial (with the exception of survival follow-up period)
PartA
12Adequate tumor tissue or cytology sample or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy
13All previous cancer therapies and any agents that have not received regulatory approval for any indication must have been discontinued
14Patient has advanced inoperable or metastatic disease
15Patient has no better treatment option available
16Measurable or non-measurable disease according to RECIST 1.1
17Histological or cytological evidence of adenocarcinoma of the stomach or GEJ or pancreas that is advanced or metastatic
PartB
12Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy
13Patient has advanced inoperable or metastatic disease
14Patient must have at least one measurable lesion according to RECIST 1.1
Patients with gastric/GEJ adenocarcinoma (gastric B)
15Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced or metastatic
16Must have HER2-negative tumors
Patients with pancreatic adenocarcinoma (pancreatic B)
15Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic
PartC
12Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy. Tumor sample must have CLDN18.2 expression using a central immunohistochemistry method.
13All previous cancer therapies and any agents that have not received regulatory approval for any indication must have been discontinued
14Patient has advanced inoperable or metastatic disease
15Measurable disease according to RECIST 1.1.
Patients with gastric/GEJ adenocarcinoma (gastric C)
16Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced or metastatic
17Must have received at least two prior systemic therapies for advanced or metastatic disease.
Patients with pancreatic adenocarcinoma (pancreatic C)
16Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic
17Must have received at least one prior systemic therapy for advanced or metastatic disease If HER2 overexpression: must have received anti-HER2 therapy.
Part D
12Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy. Tumor sample must have CLDN18.2 expression using a central immunohistochemistry method.
13Patient must have at least one measurable lesion according to RECIST 1.1. At least one measurable lesion must be outside of an earlier radiation field or must have progressed after radiation therapy.
Patients with gastric/GEJ adenocarcinoma (gastric D)
14Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced inoperable or metastatic
15Must have HER2-negative tumors
Patients with pancreatic adenocarcinoma (pancreatic D)
14Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced inoperable or metastatic

Criterios de inclusión para todas las partes del ensayo
1Edad≥18 años
2Consentimiento informado por escrito dado antes de cualquier procedimiento específico del ensayo
3Función orgánica adecuada evaluada por los siguientes parámetros: hematológicos; hepáticos; renales; tiempo de protrombina/relación internacional normalizada (INR); albúmina; proteinuria
4Estado de rendimiento≤1 del Grupo Oncológico Cooperativo del Este (ECOG)
5Esperanza de vida estimada≥3 meses según la evaluación del investigador
6Una paciente femenina es elegible para participar si no está embarazada, no está amamantando y se aplica una de las siguientes condiciones:
6.1No es una mujer en edad fértil (MEF).MEF se define como fértil, después de menarquia y hasta convertirse en posmenopáusica, a menos que sea permanentemente estéril
6.2MEF que se compromete a utilizar un método anticonceptivo muy eficaz durante el período de tratamiento y durante al menos 9m después de la última dosis de SOT102
7Los pacientes varones deben aceptar utilizar un preservativo durante el tratamiento y durante los 9m posteriores a la interrupción del tratamiento con SOT102 o del tratamiento de primera línea con EoC
8Fracción de eyección del ventrículo izquierdo (FEVI)≥50% determinada por ecocardiografía o metodología de medicina nuclear (escáner de adquisición múltiple [MUGA])
9Intervalo QTcF<450 mseg en el electrocardiograma (ECG) de cribado
10El paciente es, a juicio del investigador, un candidato apropiado para la terapia experimental
11El paciente acepta no participar en otros ensayos clínicos de intervención mientras esté inscrito en el presente ensayo (con la excepción del período de seg. de la supervivencia)
ParteA
12Tejido tumoral adecuado o muestra citológica o portaobjetos sin teñir de una biopsia de archivo disponible o voluntad de someterse a una nueva biopsia tumoral
13Todas las terapias anteriores contra el cáncer y cualquier agente que no haya recibido la aprobación reglamentaria para cualquier indicación deben haber sido suspendidas
14El paciente tiene una enfermedad avanzada inoperable o metastásica
15El paciente no tiene ninguna opción de tratamiento mejor disponible
16Enfermedad medible o no medible según RECIST 1.1
17Evidencia histológica o citológica de adenocarcinoma de estómago o de la JE o de páncreas avanzado o metastásico
ParteB
12Se dispone de una muestra adecuada de tejido tumoral o de citología (bloques FFPE) o de portaobjetos no teñidos de una biopsia de archivo, o se está dispuesto a someterse a una nueva biopsia tumoral
13El paciente tiene una enfermedad avanzada inoperable o metastásica
14El paciente debe tener al menos una lesión medible según RECIST 1.1
Pacientes con adenocarcinoma gástrico/GEJ (gástrico B)
15Evidencia histológica o citológica de adenocarcinoma de estómago o GEJ avanzado o metastásico
16Tener tumores HER2-negativos
Pacientes con adenocarcinoma de páncreas (pancreático B)
15Evidencia histológica o citológica de adenocarcinoma de páncreas avanzado o metastásico
ParteC
12Muestra adecuada de tejido tumoral o citología (bloques FFPE) o portaobjetos sin teñir de una biopsia de archivo disponible o voluntad de someterse a una biopsia tumoral en fresco. La muestra tumoral debe tener expresión de CLDN18.2 mediante un método de inmunohistoquímica central
13Todas las terapias anteriores contra el cáncer y cualquier agente que no haya recibido aprobación reglamentaria para cualquier indicación deben ser suspendidas
14El paciente tiene una enfermedad avanzada inoperable o metastásica
15Enfermedad medible según RECIST 1.1
Pacientes con adenocarcinoma gástrico/GEJ (gástrico C)
16Evidencia histológica o citológica de adenocarcinoma de estómago o GEJ avanzado o metastásico
17Haber recibido al menos dos terapias sistémicas previas para la enfermedad avanzada o metastásica
Pacientes con adenocarcinoma de páncreas (pancreático C)
16Evidencia histológica o citológica de adenocarcinoma de páncreas avanzado o metastásico
17Haber recibido al menos una terapia sistémica previa por enfermedad avanzada o metastásica Si hay sobreexpresión de HER2: haber recibido terapia anti-HER2
Parte D
12Muestra adecuada de tejido tumoral o citología (bloques FFPE) o portaobjetos sin teñir de biopsia de archivo disponible o voluntad de someterse a biopsia tumoral en fresco. La muestra tumoral debe tener expresión de CLDN18.2 mediante método de inmunohistoquímica central
13El paciente debe tener al menos una lesión medible según RECIST 1.1. que debe estar fuera de un campo de radiación anterior o debe haber progresado después de la radioterapia
Pacientes con adenocarcinoma gástrico/GEJ (D gástrico)
14Evidencia histológica o citológica de adenocarcinoma de estómago o GEJ avanzado inoperable o metastásico
15Tener tumores HER2-negativos
Pacientes con adenocarcinoma de páncreas (pancreático D)
14Evidencia histológica o citológica de adenocarcinoma de páncreas avanzado, inoperable o metastásico

E.4

Principal exclusion criteria

1.Prior therapy with any agent directed at CLDN18.2
2.Patient has received radiation therapy ≤14 days before day 1 of cycle 1 or has not recovered to grade ≤1 from treatment-related side effects
3.Severe preexisting medical conditions as per judgement of the investigator
4.History of interstitial pneumonitis or pulmonary fibrosis
5.Symptomatic central nervous system malignancy. Patients with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days.
6.Patient has peripheral sensory neuropathy grade ≥2
7.Active infection requiring systemic therapy within ≤7 days prior to day 1 of cycle 1
8.Known history of HIV infection or known active hepatitis B or hepatitis C
9.Alcohol or drug abuse as determined by the investigator
10.Psychiatric condition or social situation that, in the opinion of the investigator, preclude that the patient is able to comply with trial requirements
11.New York Heart Association class ≥3 heart failure, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, myocardial infarction, cerebrovascular accident or hypertensive crisis within 6 months prior to day 1 of cycle 1
12.History of major ventricular arrhythmias
13.History or family history of congenital long QT syndrome
14.Major surgical intervention ≤28 days prior to ICF signature or incomplete wound healing after surgical intervention
15.Hypersensitivity or intolerance to any component of trial intervention
Part A Part B Part C and part D:
16.Any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer.
Part B
17.Any prior systemic therapy for metastatic cancer other than gastric
or pancreatic cancer.
Patients with gastric/GEJ adenocarcinoma (gastric B) only:
18. Dihydropyrimidine dehydrogenase (DPD) deficiency
19. Patient has been treated with immunosuppressive medications ≤14 days prior to day 1 of cycle 1.
Part D
17.Patients with contraindications to any component of the first-line SoC treatment
Patients with gastric/GEJ adenocarcinoma (gastric D) only:
18.DPD deficiency
19.Patient has been treated with immunosuppressive medications ≤14 days prior to day 1 of cycle 1

1.Terapia previa con cualquier agente dirigido al CLDN18.2
2.El paciente ha recibido radioterapia ≤14 días antes del día 1 del ciclo 1 o no se ha recuperado hasta un grado ≤1 de los efectos secundarios relacionados con el tratamiento
3.Condiciones médicas preexistentes graves a juicio del investigador
4.Antecedentes de neumonitis intersticial o fibrosis pulmonar
5.Malignidad sintomática del sistema nervioso central. Los pacientes con metástasis asintomáticas o tratadas en el sistema nervioso central pueden ser elegibles si no están tratados con corticosteroides o anticonvulsivos y la enfermedad está estable durante al menos 60 días.
6.El paciente tiene una neuropatía sensorial periférica de grado ≥2
7.Infección activa que requiera tratamiento sistémico en los ≤7 días anteriores al día 1 del ciclo 1
8.Antecedentes conocidos de infección por VIH o hepatitis B o hepatitis C activa conocida
9.Abuso de alcohol o drogas según lo determine el investigador
10.Condición psiquiátrica o situación social que, en opinión del investigador, impida que el paciente sea capaz de cumplir con los requisitos del ensayo
11.Insuficiencia cardíaca de clase ≥3 de la New York Heart Association, angina inestable, angioplastia coronaria, colocación de stent coronario, injerto de derivación arterial coronaria, infarto de miocardio, accidente cerebrovascular o crisis hipertensiva en los 6 meses anteriores al día 1 del ciclo 1
12.Antecedentes de arritmias ventriculares importantes
13.Historia o antecedentes familiares de síndrome de QT largo congénito
14.Intervención quirúrgica mayor ≤28 días antes de la firma de la CIF o cicatrización incompleta de la herida tras la intervención quirúrgica
15.Hipersensibilidad o intolerancia a cualquier componente de la intervención del ensayo
Parte A Parte B Parte C y parte D:
16.Cualquier terapia sistémica previa para el cáncer metastásico que no sea cáncer gástrico o pancreático.
Parte B
17.Cualquier tratamiento sistémico previo para el cáncer metastásico que no sea cáncer gástrico o de páncreas.
gástrico o de páncreas.
Pacientes con adenocarcinoma gástrico/GEJ (gástrico B) solamente:
18. Deficiencia de dihidropirimidina deshidrogenasa (DPD)
19. El paciente ha sido tratado con medicamentos inmunosupresores ≤14 días antes del día 1 del ciclo 1.
Parte D
17.Pacientes con contraindicaciones a cualquier componente del tratamiento de primera línea de SoC
Pacientes con adenocarcinoma gástrico/GEJ (D gástrico) únicamente:
18.Deficiencia de DPD
19.El paciente ha sido tratado con medicamentos inmunosupresores ≤14 días antes del día 1 del ciclo 1

E.5 End points

E.5.1

Primary end point(s)

Part A-B :MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT)-evaluable patients experiencing a DLT. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested.
Part C (SOT102 monotherapy, cohort expansion)
Objective response rate (ORR)
Part D (SOT102 combined with first-line SoC treatment, cohort expansion)
ORR

Parte A-B: La DPM se define como el nivel de dosis más alto probado por debajo del nivel de dosis asociado con ≥33% de los pacientes evaluables por toxicidad limitante de la dosis (DLT) que experimentan una DLT. La RP2D se seleccionará basándose en la evaluación integrada de la totalidad de los datos clínicos y preclínicos, para todos los niveles de dosis probados.
Parte C (monoterapia con SOT102, ampliación de la cohorte)
Tasa de respuesta objetiva (ORR)
Parte D (SOT102 combinado con el tratamiento de primera línea con SoC, ampliación de la cohorte)
ORR

E.5.1.1

Timepoint(s) of evaluation of this end point

N/A

E.5.2

Secondary end point(s)

The occurrence of DLTs, occurrence of treatment-emergent AEs (TEAEs), SOT102- related AEs, serious AEs (SAEs), AEs leading to premature discontinuation of SOT102, deaths, or clinical laboratory test abnormalities
• PK of total SOT102, conjugated SOT102, PNU-EDA-GGT (M4), PNU-EDA-GG (M5), and PNU-EDA-G (M6)
• Anecdotal tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by type and CLDN18.2 expression. The number of patients with detected antibodies against any part of SOT102
Additionally for PartC & Part D
Assessment of global and disease-specific QoL by patient-reported questionnaires EORTC
QLQ-C30 and EORTC QLQ-STO22 for patients with gastric cancer, and EORTC QLQC30
and EORTC QLQ-PAN26 for patients with pancreatic cancer
Part D in additon:
DoR and PFS per RECIST 1.1, OS

La aparición de DLT, la aparición de EA emergentes del tratamiento (TEAE), EA relacionados con SOT102, EA graves (SAE), EA que conducen a la interrupción prematura de SOT102, muertes o anomalías en las pruebas de laboratorio clínico
- PK de SOT102 total, SOT102 conjugado, PNU-EDA-GGT (M4), PNU-EDA-GG (M5) y PNU-EDA-G (M6)
- Respuesta tumoral anecdótica según los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) 1.1 por tipo y expresión de CLDN18.2. El número de pacientes con anticuerpos detectados contra cualquier parte de SOT102
Además, para la Parte C y la Parte D
Evaluación de la calidad de vida global y específica de la enfermedad mediante los cuestionarios EORTC
QLQ-C30 y EORTC QLQ-STO22 para pacientes con cáncer gástrico, y EORTC QLQC30
y EORTC QLQ-PAN26 para pacientes con cáncer de páncreas
Parte D adicional:
DoR y PFS según RECIST 1.1, OS

E.5.2.1

Timepoint(s) of evaluation of this end point

N/A

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

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)

Yes

E.7.1.1

First administration to humans

Yes

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

Yes

E.8.1.7.1

Other trial design description

Bifurcado_Parte A y Parte B, y sus respectivas ampliaciones

Bifurcated_Part A and Part B, and their respective expansions

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

Belgium

Czechia

France

Spain

United States

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

LVLS including follow-up calls.

LVLS incluidas las llamadas de seguimiento

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)

Yes

F.1.2.1

Number of subjects for this age range:

134

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

135

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

176

F.4.2.2

In the whole clinical trial

269

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

2022-04-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-04-25

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

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