Etude : SYD1875.001 /

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Type d'étude
Présentation de l'étude
Acronyme : SYD1875.001

Nom :

Traitement : Métastatique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 29/05/2020
CIM10 - Localisation(s)
Informations principales
Titre : A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With 5T4-expressing Locally Advanced or Metastatic Solid Tumours

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Informations complémentaires
Schéma : Cancer cells can have different kinds of proteins on their cell surface; one of these is the oncofetal antigen 5T4. 5T4 plays an important role in the development of cancer. Currently no drugs are available that work via the 5T4 antigen.

The new cancer drug SYD1875 is being developed by Synthon Biopharmaceuticals BV. SYD1875 is an antibody-drug conjugate and consists of two parts: an antibody and a linker-drug moiety containing a toxin. The antibody part binds to 5T4 on the surface of the cancer cell. When SYD1875 binds to this cancer cell, it will be internalized by the cell. After proteolytic cleavage of the linker, the toxin will be split off in the cell and the cancer cell will be killed. Thus, SYD1875 can be considered as a form of targeted chemotherapy.

This is the first study in which SYD1875 is administered to humans. The study consists of two parts:

Part 1 is the dose-escalation part in which a low dose of SYD1875 is given to cancer patients. If it is well tolerated, a higher dose of SYD1875 will be given to other cancer patients until the maximum tolerated dose is reached.

In Part 2 of the study, groups of patients with a specific type of cancer will receive the SYD1875 dose which has been selected for further evaluation.

All patients from both parts of the study will receive SYD1875 infusions every three weeks until progression of the cancer or unacceptable toxicity develops.

Phase : I

Stade : Localement avancé à Métastasique

2, 3, 4, X
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : Main Inclusion Criteria:

Patient with histologically-confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists, with the following restriction:
- Part 1: solid tumours of any origin
- Part 2: three patient cohorts
- Tumour 5T4 membrane staining according protocol
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
- Adequate organ function
- For Part 2: measurable disease

Critères de non-inclusion : Main Exclusion Criteria:
- Having been treated with:
1 5T4-targeting therapy at any time
2 Trastuzumab duocarmazine (SYD985) at any time
3 Other anticancer therapy within 4 weeks or as defined in the protocol
4 Hormone therapy within 1 week
- History or presence of keratitis, clinically significant renal disease, lung disease, or cardiovascular disease as specified in the protocol
- Symptomatic brain metastases, brain metastases requiring steroids or treatment for brain metastases within 8 weeks
Informations relatives au promoteur
Promoteur :
Synthon Biopharmaceuticals BV
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Professeur Nicolas PENEL

Unité Intégrée de Recherche Clinique

Statut de l'essai : OUVERT

MAJ : 29/05/2020