Clinical Trials Register

Summary
EudraCT Number:	2020-005427-36
Sponsor's Protocol Code Number:	NL75654.078.20
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-05-28
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

Netherlands - Competent Authority

A.2

EudraCT number

2020-005427-36

A.3

Full title of the trial

A multicenter, open label non-randomized phase I/II dose escalation study
with extension cohort to determine the safety, tolerability and immune
modulating effects of the therapeutic LRPAP1 synthetic long peptide
(LRPAP7-30V-SLP) vaccine (TEIPP24) at different doses in HLA-A*0201-
positive patients with non small cell lung cancer (NSCLC).

Een multicenter, open-label niet-gerandomiseerde fase I / II dosis
escalatie studie met extensie cohort om de veiligheid, verdraagbaarheid en
immuun modulerende effecten te bepalen van het therapeutische LRPAP1
synthetisch lange peptide (LRPAP7-30V-SLP) vaccin (TEIPP24) onder
verschillende doseringen bij HLA-A * 0201-positieve patiënten met nietkleincellige
longkanker (NSCLC).

A.3.1

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

Study of the new TEIPP24 vaccine focusing on enhancing the recognition of
cancer cells by the immune system in patients with non small cell lung
cancer.

Onderzoek naar het nieuwe TEIPP24 vaccin gericht op het verbeteren van
de herkenning van kankercellen door het afweersysteem bij patiënten met
niet-kleincellige longkanker.

A.3.2

Name or abbreviated title of the trial where available

TEIPP24

A.4.1

Sponsor's protocol code number

NL75654.078.20

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	Erasmus MC Cancer Center
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Erasmus MC Cancer Center
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Erasmus MC Cancer Center
B.5.2	Functional name of contact point	Research longziekten
B.5.3	Address:
B.5.3.1	Street Address	Postbus 2040
B.5.3.2	Town/ city	Rotterdam
B.5.3.3	Post code	3000 CA
B.5.3.4	Country	Netherlands
B.5.6	E-mail	research.longziekten@erasmusmc.nl
B.Sponsor: 2
B.1.1	Name of Sponsor	Erasmus MC Cancer Center
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Erasmus MC Cancer Center
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Erasmus MC Cancer Center
B.5.2	Functional name of contact point	Research longziekten
B.5.3	Address:
B.5.3.1	Street Address	Postbus 2040
B.5.3.2	Town/ city	Rotterdam
B.5.3.3	Post code	3000 CA
B.5.3.4	Country	Netherlands
B.5.6	E-mail	research.longziekten@erasmusmc.nl

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.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	TEIPP24
D.3.4	Pharmaceutical form	Dispersion for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
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)	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

non small cell lung cancer (NSCLC)

E.1.1.1

Medical condition in easily understood language

non small cell lung cancer (NSCLC)

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

A multicenter, open label non-randomized phase I/II dose escalation
study with extension cohort to determine the safety, tolerability and
immunogenicity of the therapeutic LRPAP1 synthetic long peptide (
LRPAP7-30V-SLP) vaccine (TEIPP24) at different doses in HLA-A*0201-
positive patients with non-small cell lung cancer (NSCLC) failing first line
therapy of checkpoint blockade with/without chemotherapy and who
can't endure or are not willing to receive 2nd line treatment with
docetaxel chemotherapy.

E.2.2

Secondary objectives of the trial

Secondary enpoints:
- The specificity and immune modulatory effects of the vaccine.
- The antigen and immune status of the patients.
- The progression free survival (PFS) and overall survival (OS) up to one
year after first vaccination.
- The radiological tumor response and tumor response duration up to
one year after first vaccination according to RECIST v.1.1 criteria.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients older than 18 years with NSCLC will be asked to participate in
this study after progression on first line treatment with chemotherapy
and immunotherapy (PD-l).
- Age >18 years
- Pathologically and radiologically confirmed advanced NSCLC.
- Progression after minimally 4 cycles of combination platinum
containing chemotherapy and immunotherapy (PD1), or after 4 cycles of
platinum containing chemotherapy and immunotherapy (PD-1) followed
by maintenance chemo immunotherapy
- HLA-A*0201 positive
- An expected survival of at least 3 months
- WHO/ECOG performance status ≤ 2
- Adequate renal function as defined by creatinine clearance > 40
mL/min based on the Cockroft-Gault glomerular filtration rate (GFR)
XML File Identifier: Jpp7lm+m9l77lGKQ81NZKtbGFcI=
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- Adequate hepatic function as evidenced by
o Serum total bilirubin ≤ 2.5 × upper limit of normal (ULN) unless
considered due to hepatic metastases
o Aspartate aminotransferase (AST), alanine aminotransferase (ALT),
and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to
hepatic metastases
- Ability to return to the hospital for adequate follow-up as required by
this protocol.
- Written informed consent according to ICH-GCP.

E.4

Principal exclusion criteria

A potential subject who meets any of the following criteria will be
excluded from participation in this study:
- Active infection, including hepatitis B or C or HIV infection that is
uncontrolled at inclusion. An infection controlled with an approved or
closely monitored antibiotic/antiviral/antifungal treatment is allowed.
- Current use of steroids (or other immunosuppressive agents).
Patients must have had
6 weeks of discontinuation and must stop any such treatment during the
time of the
study. Prophylactic usage of dexamethasone during chemotherapy is
excluded from
this 6 weeks interval.
- Concomitant participation in another clinical intervention trial (except
participation in a
biobank study).
- Pregnant or lactating women.
- Known allergy to any of the ingredients of the vaccine (peptide,
Montanide ISA-51, trifluoroacetic acid, acetonitrile, dichloromethane,
dimethylsulfoxide).
- Any medical or psychological condition deemed by the Investigator to
be likely to interfere with a patient's ability to give informed consent or
participate in the study
- Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up
schedule
- Patients with a currently active second malignancy. However, patients
with the following history/concurrent conditions are allowed: Basal or
squamous cell carcinoma of the skin; Carcinoma in situ of the cervix;
Carcinoma in situ of the breast; Incidental histologic finding of prostate
cancer.

E.5 End points

E.5.1

Primary end point(s)

Safety will be determined by the incidence rate at each dose level based
on the following safety parameters: adverse drug reactions and serious
ADRs, changes in haematology and chemistry values, including those
associated with hepatic and renal function, and assessment of physical
examinations, vital signs and performance status. NCI-CTCAE version 5.0
will be used.

E.5.1.1

Timepoint(s) of evaluation of this end point

TEIPP-specific immunity: HLA-A*0201-restricted LRPAP21-30 -specific
CD8+ T-cell reactivity will be determined by measuring the magnitude
and function of HLA-A*0201-restricted LRPAP21-30 -specific CD8+ T-cell
present in the blood and/or tumor samples before and after TEIPP24
vaccination.

E.5.2

Secondary end point(s)

End of study.
Death.

E.5.2.1

Timepoint(s) of evaluation of this end point

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

E.6.7

Pharmacodynamic

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)

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

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.8.2.4

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

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

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)

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.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.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-05-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-20

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

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