Clinical trial • Phase I • Oncology

Tislelizumab for Advanced or metastatic solid tumors | Hepatocellular carcinoma | Squamous non-small cell lung cancer | Gastric cancer

Phase I trial of Tislelizumab for Advanced or metastatic solid tumors | Hepatocellular carcinoma | Squamous non-small cell lung cancer | Gastric cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced or metastatic solid tumors | Hepatocellular carcinoma | Squamous non-small cell lung cancer | Gastric cancer
Trial Stage
Phase I
Drug Modality
Monoclonal antibody | Other

Key dates

Initial CTIS Submission Date
05-12-2025
First CTIS Authorization Date
15-04-2026

Trial design

Phase I trial across 9 sites in France, Italy.

Target Sample Size
229

Eligibility

Recruits 229 Vulnerable population not selected; no consent/assent information provided..

Vulnerable Population
Vulnerable population not selected; no consent/assent information provided.

Recruitment

Planned Sample Size
229
Recruitment Window Months
32

Geography

Total Number Of Sites
9
Total Number Of Participants
56

France

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
68
Number Of Sites
5
Number Of Participants
39

Sites

Site Name
Centr Georges Francois Leclerc
Department Name
Oncologie Medicale
Contact Person Name
Francois Ghiringhelli
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Hopital Beaujon
Department Name
Unité Cancer du foie et innovation thérapeutique
Contact Person Name
Mohamed Bouattour
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncologie Medicale
Contact Person Name
Diego Tosi
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Institut Gustave Roussy
Department Name
Département d'innovation Thérapeutique et des Essais Précoces (DITEP)
Contact Person Name
Christophe Massard
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncologie Medicale
Contact Person Name
Yann Touchefeu
Contact Person Email
xxxxxx@xxxxxxx.fr

Italy

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
33
Number Of Sites
4
Number Of Participants
17

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Sperimentazioni cliniche
Contact Person Name
Adriano Gravina
Contact Person Email
a.gravina@istitutotumori.na.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Operating Unit of Oncology and Hematology
Contact Person Name
Matteo Simonelli
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Medical Oncology
Contact Person Name
Gennaro Daniele
Site Name
Istituto Oncologico Veneto
Department Name
Medical Oncology 1 Unit
Contact Person Name
Sara Lonardi
Contact Person Email
sara.lonardi@iov.veneto.it

Sponsor

Primary sponsor

Full Name
BeOne Medicines AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
BGB-B2033
Investigational Product Name
Tislelizumab
Active Substance
Tislelizumab
Modality
Monoclonal antibody
Investigational Product Name
Bevacizumab
Active Substance
Bevacizumab
Modality
Monoclonal antibody
Combination Treatment
Yes

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