Clinical Trials Register

Summary
EudraCT Number:	2020-003096-18
Sponsor's Protocol Code Number:	ACT16432
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-02-02
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2020-003096-18

A.3

Full title of the trial

Open-label, multi-cohort, Phase 2 trial, evaluating the efficacy and safety of SAR408701 in patients with CEACAM5-positive advanced solid tumors

Nyílt címkés, multikohorszos, II. fázisú vizsgálat a SAR408701 hatásosságának és biztonságosságának értékelésére CEACAM5-pozitív, előrehaladott szolid tumorban szenvedő betegeknél

A.3.1

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

SAR408701 in patients with CEACAM5-positive advanced solid tumors

SAR408701 CEACAM5-pozitív, előrehaladott szolid tumorokban szenvedő betegeknél

A.3.2

Name or abbreviated title of the trial where available

CARMEN-BT01

A.4.1

Sponsor's protocol code number

ACT16432

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1244-1644

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	Sanofi aventis recherche & développement
B.1.3.4	Country	France
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	Sanofi-Aventis Recherche & Développement
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sanofi-Aventis Zrt.
B.5.2	Functional name of contact point	NA
B.5.3	Address:
B.5.3.1	Street Address	Tó u. 1-5.
B.5.3.2	Town/ city	Budapest
B.5.3.3	Post code	1045
B.5.3.4	Country	Hungary
B.5.6	E-mail	kapcsolat@sanofi.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.3.2	Product code	SAR408701
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	Not assigned
D.3.9.2	Current sponsor code	SAR408701
D.3.9.3	Other descriptive name	SAR408701
D.3.9.4	EV Substance Code	SUB130908
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	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Anti-CEACAM 5 antibody maytansine 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

Cancer

Rák

E.1.1.1

Medical condition in easily understood language

Cancer

Rák

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	20.1
E.1.2	Level	PT
E.1.2	Classification code	10055113
E.1.2	Term	Breast cancer metastatic
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	21.0
E.1.2	Level	PT
E.1.2	Classification code	10033610
E.1.2	Term	Pancreatic carcinoma metastatic
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 antitumor activity of SAR408701 in metastatic breast cancer (mBC) and metastatic pancreatic adenocarcinoma (mPAC)

• A SAR408701 tumorellenes aktivitásának értékelése mBC és mPAC esetén

E.2.2

Secondary objectives of the trial

• To assess the safety and tolerability of SAR408701
• To assess other efficacy parameters of SAR408701
• To assess the immunogenicity of SAR408701

• A SAR408701 biztonságossának és tolerálhatóságának értékelése
• A SAR408701 egyéb hatásossági paramétereinek értékelése
• A SAR408701 immungenitásának értékelése

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participant must be at least 18 years of age
Participants with at least one measurable lesion according to the RECIST v1.1 criteria that has not been irradiated (ie, newly arising lesions in previously irradiated areas are accepted).
Participants with ECOG performance status 0 to 1.
Evidence of metastatic disease.
Expression of CEACAM 5 by centrally assessed IHC assay.
Cohort A:
Histological or cytologic diagnosis of breast cancer.
Have received at least 2 prior cytotoxic chemotherapy regimens for non-TNBC tumor type or at least 1 for TNBC tumor type but not more than 4 in the locally recurrent or metastatic setting.
Cohort B:
Have confirmed diagnosis of pancreatic ductal adenocarcinoma.
Have documented radiographic progression or documented intolerance after at least 1 prior systemic chemotherapy line which included either gemcitabine (or relapsed within 6 months of completion of gemcitabine adjuvant therapy) or a 5-fluorouracil based regimen (including capecitabine) but no more than 2 prior chemotherapy lines for locally advanced/metastatic disease.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Capable of giving signed informed consent

A résztvevőknek legalább 18 (vagy az országban érvényes nagykorúsági kor, ha az > 18) évesnek kell lenniük a tájékoztatás utáni beleegyező nyilatkozat aláírásakor.
Azok a résztvevők, akiknél a RECIST v1.1 kritériumok szerint legalább egy mérhető lézió nem került besugárzásra (azaz a korábban besugárzott területeken újonnan kialakuló léziók elfogadottak).
Azok a résztvevők, akik ECOG teljesítménystátusza 0 és 1 között van.
Metasztatikus betegség bizonyítéka.
A CEACAM5 expressziója, központilag értékelt IHC-teszttel
'A' kohorsz:
Emlőrák hisztológiai vagy citológiai diagnózisa.
Legalább 2 korábbi citotoxikus kemoterápiás kezelési sémát kapott nem TNBC tumortípusra, vagy legalább 1-et a TNBC tumortípusra, de legfeljebb 4-et a lokálisan kiújuló vagy metasztatikus betegségre.
'B' kohorsz:
Hasnyálmirigy duktális adenokarcinóma diagnózisának igazolása.
Dokumentált radiológiai progresszió vagy dokumentált intolerancia legalább 1 korábbi szisztémás kemoterápiás vonal után, amely vagy gemcitabint (vagy a gemcitabin adjuváns terápia befejezését követő 6 hónapon belül relapszust) vagy 5-fluor-uracil alapú kezelést (beleértve a kapecitabint is) foglal magában, de legfeljebb 2 korábbi kemoterápiás vonal a lokálisan előrehaladott/metasztatikus betegségre
A férfiak és nők által alkalmazott fogamzásgátlás alkalmazásának összhangban kell állnia a klinikai vizsgálatokban részt vevők számára előírt helyi szabályozással.
Képes aláírt, tájékoztatás utáni beleegyezést adni

E.4

Principal exclusion criteria

Participants are excluded from the study if any of the following criteria apply:
Medical conditions
- Medical condition requiring concomitant administration of a medication with a narrow therapeutic window, that is metabolized by cytochrome P450 (CYP450), and for which a dose reduction cannot be considered.
- Medical conditions requiring concomitant administration of strong CYP3A inhibitor, unless it can be discontinued at least 2 weeks before the first administration of study intervention.
- Life expectancy less than 3 months.
- Untreated brain metastases or history of leptomeningeal disease.
- Significant concomitant illness
- History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or active hepatitis A, B or C infection.
- Non-resolution of any prior treatment-related toxicity to <Grade 2 according to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy (HRT).
- Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy.
- Use of contact lenses. Participants using contact lenses who are not willing to stop wearing them for the duration of the study intervention are excluded.

Prior/concomitant therapy
- Concurrent treatment with any other anti cancer therapy.
- Washout period before the first administration of study intervention of less than 3 weeks or less than 5 times the half-life, whichever is shorter, for prior antitumor therapy (chemotherapy, targeted agents, immunotherapy and radiotherapy, or any investigational treatment).
- Any prior therapy targeting CEACAM5.
- Prior maytansinoid DM4 treatment (ADC).
- Any major surgery within the preceding 2 weeks of the first study intervention administration.

Prior/concurrent clinical study experience
- Previous enrollment in this study or current participation in any other clinical study involving an investigational study treatment or any other type of medical research.

Diagnostic assessments
- Poor renal function
- Poor hepatic function
- Poor bone marrow function

E.5 End points

E.5.1

Primary end point(s)

Objective Response Rate (ORR) of SAR408701, defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

A SAR408701 objektív válaszaránya (ORR), meghatározva azon résztvevők arányában, akiknél teljes választ (CR) vagy részleges választ (PR) erősítettek meg a Válaszadási kritériumok értékelése a szolid tumorokban (RECIST) 1.1 szerint

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline up to 6 months after the last patient treated have 2 postbaseline tumor assessments

E.5.2

Secondary end point(s)

1. Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 - TEAEs, SAEs and laboratory abnormalities according to NCI CTCAE v5.0

2. Progression free survival (PFS) - PFS defined as the time from the date of first SAR408701 administration to the date of the first documented disease progression or death due to any cause, whichever comes first

3. Disease control rate (DCR) - DCR defined as the percentage of participants who have achieved CR, PR or stable disease as per RECIST v1.1

4. Duration of Response (DOR) - DOR defined as the time from first documented evidence of CR or PR until progressive disease determined per RECIST v1.1 or death from any cause, whichever occurs first

5. Incidence of participants with anti-therapeutic antibodies (ATAs) against SAR408701

1. A kezelés során előforduló nemkívánatos eseményeket (TEAE-k), súlyos nemkívánatos eseményeket (SAE-k) és laboratóriumi rendellenességeket tapasztaló résztvevők előfordulása a National Cancer Institute (NCI) nemkívánatos eseményekre vonatkozó közös terminológia-kritériumai (CTCAE) V5.0 szerint

2. A progressziómentes túlélés (PFS) a meghatározás szerint a SAR408701 első beadásának napjától a betegségprogresszió első dokumentálásának dátumáig, vagy a bármely okból történő elhalálozás dátumáig eltelt idő, bármelyik is következik be előbb.

3. Betegségkontroll arány (DCR), azaz azon résztvevők százalékos aránya, akik a RECIST v1.1 szerint CR-t, PR-t vagy stabil betegséget értek el

4. A válasz időtartam (DOR) definíció szerint a CR vagy PR első dokumentált bizonyítékától a RECIST v1.1 szerint megállapított progresszív betegségig vagy a bármely okból bekövetkező elhalálozásig számított idő

5. A SAR408701 elleni gyógyszerellenes antitestekkel (ATA) rendelkező résztvevők előfordulása

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Baseline up to 90 days after the last study treatment administration

2. 3. and 4. Baseline up to 6 months after the last patient treated have 2 postbaseline tumor assessments

5. Baseline up to end of study

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

E.6.6

Pharmacokinetic

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

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

E.8.3

The trial involves single site in the Member State concerned

Information not present in EudraCT

E.8.4

The trial involves multiple sites in the Member State concerned

Information not present in EudraCT

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

Argentina

Chile

Korea, Republic of

Russian Federation

Taiwan

Turkey

United States

France

Hungary

Netherlands

Spain

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

LVLS

Utolsó beteg utolsó vizit

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

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)

None

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

2021-03-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-23

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-12-20

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IMP with orphan designation in the indication
Orphan Designation Number:
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