RIVKAL clinical trial for the first-in-human administration of BIM2b in participants with Glioblastoma

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol 2024-BI-01 (RIVKAL)

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruitment pending

Participants planned 36

Countries 1

Sites 1

Glioblastoma

Key facts

Sponsor: Beta Innov
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Decision date (initial): 2024-10-09
Transition trial: No
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Glioblastoma

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Beta Innov

Sponsor organisation: Beta Innov
Address: 49 Rue Rouelle
City: Paris
Postcode: 75015
Country: France

Scientific contact point

Organisation: Beta Innov
Contact name: Beta Innov

Public contact point

Organisation: Beta Innov
Contact name: Beta Innov

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Authorised, recruitment pending	36	1
Rest of world	—	0	—

Investigational sites

France

1 site · Authorised, recruitment pending

Hopital D'Instruction Des Armees Percy

Service de Neurologie, 101 Avenue Henri Barbusse, 92140, Clamart

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-07-24	France	Acceptable 2024-10-09	2024-10-09