Clinical Trials Register

Summary
EudraCT Number:	2022-000135-23
Sponsor's Protocol Code Number:	BA3011-002
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:	2022-07-05
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

2022-000135-23

A.3

Full title of the trial

A Phase 2 Study of Mecbotamab Vedotin (BA3011) Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer Who Had Prior Disease Progression On or Are Intolerant to a PD-1/L1, EGFR, or ALK Inhibitor

Estudio de fase 2 para evaluar la administración de mecbotamab vedotin (BA3011) en monoterapia y en combinación con nivolumab en pacientes adultos con cáncer de pulmón no microcítico metastásico que hayan presentado progresión de la enfermedad durante un tratamiento con un inhibidor del PD-1/L1, el EGFR o la ALK o intolerancia a dicho tratamiento

A.3.1

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

A Phase 2 Study of BA3011 Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer

Estudio de fase 2 de BA3011 en monoterapia y en combinación con nivolumab en pacientes adultos con cáncer de pulmón no microcítico metastásico

A.4.1

Sponsor's protocol code number

BA3011-002

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04681131

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	BioAtla Inc.
B.1.3.4	Country	United States
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	BioAtla 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	BioAtla Inc.
B.5.2	Functional name of contact point	Ji Hwan Lee
B.5.3	Address:
B.5.3.1	Street Address	11085 Torreyana Rd, Suite 100
B.5.3.2	Town/ city	San Diego
B.5.3.3	Post code	CA 92121
B.5.3.4	Country	United States
B.5.4	Telephone number	+18585580708
B.5.6	E-mail	Clinicaltrials@bioatla.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	Mecbotamab Vedotin
D.3.2	Product code	BA3011
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	NA
D.3.9.1	CAS number	2460400-28-4
D.3.9.2	Current sponsor code	BA3011
D.3.9.3	Other descriptive name	Humanised IgG1 [de-450-lysine] monoclonal antibody against AXL conjugated to N-[[[4-[[N-[6-(3-mercapto2,5-dioxo-1-pyrrolidinyl)-1-oxohexyl]-L-valy-l-N5-(aminocarbonyl)-Lornithyl]amino]phenyl]methoxy]carbonyl]-N-methyl-L-valyl-N-[(1S,2R)-4-[(2S)-2- [(1R,2R)-3-[[(1R,2S)-2-hydroxy-1-methyl-2-phenylethyl]amino]-1-methoxy-2-methyl3-oxopropyl]-1-pyrrolidinyl]-2-methoxy-1-[(1S)-1-methylpropyl]-4-oxobutyl]-N-methylL-valinamide
D.3.9.4	EV Substance Code	SUB253534
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	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	Yes
D.2.1.1.1	Trade name	OPDIVO
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Nivolumab
D.3.2	Product code	BMS-936558
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	Nivolumab
D.3.9.1	CAS number	946414-94-4
D.3.9.2	Current sponsor code	BMS-936
D.3.9.3	Other descriptive name	Opdivo
D.3.9.4	EV Substance Code	SUB122750
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	10
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

Metastatic Non-Small Cell Lung Cancer

Cáncer de pulmón de células no pequeñas metastásico

E.1.1.1

Medical condition in easily understood language

Lung Cancer

Cáncer de pulmón

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	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung cancer
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

Primary:
• To assess antitumor activity of BA3011 alone and in combination with nivolumab.
• To assess the safety of BA3011 alone and in combination with nivolumab.

Principal:
• Evaluar la actividad antineoplásica de BA3011 en monoterapia o en combinación con nivolumab.
• Evaluar la seguridad de BA3011 en monoterapia o en combinación con nivolumab.

E.2.2

Secondary objectives of the trial

Secondary:
• To further characterize the clinical activity of BA3011 alone and in combination with nivolumab.

Exploratory:
• To assess the pharmacokinetics (PK) of BA3011 alone and in combination with nivolumab.
• To evaluate the immunogenicity of BA3011 alone and in combination with nivolumab.
• To further explore the relationship between tumor AXL status and clinical response to BA3011.
• To evaluate potential candidate tumor and blood-based biomarkers for patient selection or correlation with antitumor activity of BA3011.

Secundario:
• Caracterizar en mayor medida la actividad clínica de BA3011 en monoterapia o en combinación con nivolumab.

Exploratorios:
• Evaluar la farmacocinética (FC) de BA3011 en monoterapia o en combinación con nivolumab.
• Evaluar la inmunogenia de BA3011 en monoterapia o en combinación con nivolumab.
• Explorar en mayor medida la relación entre el estado de expresión del AXL en el tumor y la respuesta clínica a BA3011.
• Evaluar los posibles biomarcadores tumorales y sanguíneos para la selección de pacientes o para establecer la relación con la actividad antineoplásica de BA3011

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients must:
- Have histologically or cytologically confirmed locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC).
- Age ≥ 18 Year.
- Adequate renal function.
- Adequate liver function.
- Adequate hematological function
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least three months

Los pacientes deben:
- Presentar cáncer de pulmón no microcítico (CPNM) localmente avanzado e irresecable o metastásico, confirmado histológica y/o citológicamente.
- Tener ≥18 años de edad.
- Función renal adecuada.
- Función hepática adecuada.
- Función hematológica adecuada.
- Presentar una categoría funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1.
- Tener una esperanza de vida de al menos 3 meses.

E.4

Principal exclusion criteria

- Clinically significant cardiac disease.
- Known non-controlled central nervous system (CNS) metastasis.
- Prior therapy with a conjugated or unconjugated auristatin derivative / vinca-binding site targeting payload.
- A history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
- Major surgery within 4 weeks before first BA3011 administration.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Women who are pregnant or breast feeding

- Cardiopatía clínicamente significative.
- Presencia de metástasis sin controlar en el sistema nervioso central (SNC).
- Tratamiento previo con un derivado de la auristatina (conjugado o sin conjugar) / una carga activa dirigida al sitio de unión a la vinca.
- Antecedentes de reacciones alérgicas de grado ≥3 al tratamiento con AcM, así como presencia o sospecha de alergia o intolerancia a cualquiera de los medicamentos que se administrarán durante este estudio.
- Haberse sometido a una intervención de cirugía mayor en el transcurso de las 4 semanas anteriores a la primera administración de BA3011.
- Antecedentes de resultados positivos en pruebas del virus de la inmunodeficiencia humana (VIH) o presencia de inmunodeficiencia adquirida (sida).
- Mujeres embarazadas o en período de lactancia.

E.5 End points

E.5.1

Primary end point(s)

Efficacy: objective response rate (ORR).
Safety: AEs, serious adverse events (SAEs), and changes from baseline in laboratory
parameters and vital signs.

Eficacia: La tasa de respuesta objetiva (TRO).
Seguridad: AAs, eventos adversos graves (EAGs), y cambios desde el inicio en los parámetros de laboratorio y signos vitals.

E.5.1.1

Timepoint(s) of evaluation of this end point

Objective response rate (ORR) is defined as the proportion of subjects with a best overall response of confirmed CR or confirmed PR that occur prior to the initiation of subsequent anticancer treatment.

La tasa de respuesta objetiva (TRO) se define como la proporción de pacientes que presenten una mejor respuesta global de RC confirmada o de RP confirmada que se produzca antes del inicio del tratamiento antineoplásico posterior.

E.5.2

Secondary end point(s)

Efficacy:
o Duration of response (DOR)
o Progression-free survival (PFS)
o Best overall response (BOR)
o Disease control rate (DCR)
o Time to response (TTR)
o Overall survival (OS)
o Percent change from baseline in target lesion sum of diameters

Eficacia:
o Duración de la Respuesta (DDR)
o Supervivencia sin Progresión (SSP)
o Mejor Respuesta Global (MRG)
o Tasa de control de la enfermedad (TCE)
o Tiempo transcurrido hasta la respuesta (TTR)
o Supervivencia global (SG)
o Cambio porcentual desde el inicio en el tamaño del tumor

E.5.2.1

Timepoint(s) of evaluation of this end point

DOR is defined as the time from the first documented OR until the first documented disease progression or death, whichever occurs first. PFS is defined as the time from the first dose of IP until the first documentation of disease progression or death. BOR will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy. DCR is defined as the proportion of pts with a best overall response of confirmed CR, confirmed PR, or stable disease (SD)≥12 weeks. Duration of SD is defined as the time from the first dose of IP until the first documentation of disease progression or death. TTR is defined as the time from the first dose of IP until the first documentation of OR. OS is defined as the time from the first dose of BA3021 until death.

DDR es el tiempo entre la primera RO documentada hasta la primera progresión de la enfermedad documentada o muerte, lo que ocurra primero. La SSP es el tiempo entre la primera dosis de IP hasta la primera documentación de progresión o muerte. El MRG se basará en todas las evaluaciones de la enfermedad posteriores a la línea base que se produzcan antes del inicio de la terapia anticancerosa posterior. TCE es la proporción de pacientes con mejor respuesta global de RC confirmada, RP confirmada o enfermedad estable (EE)≥12 semanas. EE es el tiempo entre la primera dosis de PI hasta la primera
documentación de progresión o muerte. El TTR es el tiempo entre la primera dosis de PI hasta la primera documentación de RO. La SG es el tiempo entre la primera dosis de BA3021 hasta la muerte.

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

Hong Kong

Taiwan

United States

France

Poland

Spain

Germany

Greece

Italy

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

Ultima visita del ultimo paciente

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:

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

105

F.4.2.2

In the whole clinical trial

134

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)

as per standard of care

según el estándar de atención

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

2022-09-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-14

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

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