Clinical trial • Phase I/II • Oncology

BGB-58067 (PRMT5 inhibitor) for Advanced solid tumours with MTAP homozygous deletion and/or loss of MTAP protein expression|Non-small cell lung cancer|Metastatic glioma|Cholangiocarcinoma|Pancreatic adenocarcinoma|Biliary tract neoplasm

Phase I/II trial of BGB-58067 (PRMT5 inhibitor) for Advanced solid tumours with MTAP homozygous deletion and/or loss of MTAP protein expression|Non-small…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced solid tumours with MTAP homozygous deletion and/or loss of MTAP protein expression|Non-small cell lung cancer|Metastatic glioma|Cholangiocarcinoma|Pancreatic adenocarcinoma|Biliary tract neoplasm
Trial Stage
Phase I/II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
25-10-2024
First CTIS Authorization Date
29-01-2025

Trial design

Phase I/II trial across 10 sites in Spain, France, Denmark.

Biomarker Stratified
True, MTAP homozygous deletion and/or loss of MTAP protein expression
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
501

Eligibility

Recruits 501 Vulnerable population selected; no details on consent or assent handling provided in source..

Vulnerable Population
Vulnerable population selected; no details on consent or assent handling provided in source.

Recruitment

Planned Sample Size
501
Recruitment Window Months
25

Geography

Total Number Of Sites
10
Total Number Of Participants
79

Spain

Earliest CTIS Part Ii Submission Date
10-01-2025
Latest Decision Or Authorization Date
06-04-2026
Processing Time Days
451
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Jorge Bartolome Arcilla
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Irene Brana Garcia
Contact Person Email
ibrana@vhio.net
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Irene Moreno Candilejo
Contact Person Email
irene.moreno@startmadrid.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Victor Moreno Garcia
Contact Person Email
victor.moreno@startmadrid.com

France

Earliest CTIS Part Ii Submission Date
03-02-2025
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
421
Number Of Sites
5
Number Of Participants
40

Sites

Site Name
Institut Paoli Calmettes
Department Name
oncology department
Contact Person Name
Cécile Vicier
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Institut Gustave Roussy
Department Name
Department of Drug Development
Contact Person Name
Sophie Postel-Vinay
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Institut Bergonie
Department Name
Medical oncology
Contact Person Name
Antoine Italiano
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Institut Curie
Department Name
Department of Drug Development and Innovation (D3i)
Contact Person Name
Marie-Paule Sablin
Contact Person Email
xxxxxx@xxxxxxx.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Ludovic Doucet
Contact Person Email
xxxxxx@xxxxxxx.fr

Denmark

Earliest CTIS Part Ii Submission Date
12-05-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
330
Number Of Sites
1
Number Of Participants
9

Sites

Site Name
Rigshospitalet
Department Name
Oncology
Contact Person Name
Martin Højgaard
Contact Person Email
martin.hoejgaard@regionh.dk

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
BGB-58067
Active Substance
BGB-58067 (PRMT5 inhibitor)
Modality
Small molecule
Combination Treatment
Yes

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