* BE43244-RO7444973 IN PARTICIPANTS WITH MAGE-A4-POSITIVE SOLID TUMOURS
Research type
Research Study
Full title
AN OPEN-LABEL, MULTICENTER, PHASE I STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF RO7444973 IN PARTICIPANTS WITH UNRESECTABLE AND/OR METASTATIC MAGE-A4-POSITIVE SOLID TUMORS
IRAS ID
304627
Contact name
Juanita Lopez
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2021-000624-35
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 6 months, 30 days
Research summary
Study BE43244 is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973. The study will include participants with unresectable and/or metastatic MAGE-A4 positive solid tumours carrying the HLA A*02:01 allele. The study consists of three parts:
Part I is a dose escalation study for doses predicted to be below the pharmacologically active dose (PAD). The doses are low in this part of the study as the safety profile is not known at this time Part II is a multiple participant cohort (MPC) dose-escalation study to determine the maximum tolerated dose (MTD) as well as the optimal dosing regimen of and Part III is a dose expansion study to evaluate the safety and preliminary efficacy of the Recommended Phase II Dose (RP2D). Approximately 260 participants will take part in this study: approximately 180 participants in Parts I and II, and approximately 80 participants in Part III. The length of time participants are expected to take part in this study will be approximately 40 months: Approximately 16 months pre-screening until end of safety follow up period, then up to 24 months survival follow up period. This will be the first time that RO7444973 will be given to humans.
The study is sponsored by F. Hoffman La Roche.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0265
Date of REC Opinion
25 Oct 2021
REC opinion
Further Information Favourable Opinion