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- trontinemab (RG6102) / Roche
Latest Interim Results from the BrainshuttleTM AD Study, a Phase Ib/IIa Study of Trontinemab in People with Alzheimer's Disease () - Sep 24, 2024 - Abstract #CTAD2024CTAD_342;
- De novo designed TfR1 binding peptide to shuttle antibody therapeutics across blood brain barrier () - Aug 31, 2024 - Abstract #CTAD2024CTAD_233;
- || trontinemab (RG6102) / Roche
Trial completion date, Trial primary completion date: BP42155: Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Jun 24, 2024
P1/2, N=285, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Sep 2027 --> Dec 2028 | Trial primary completion date: Sep 2027 --> Dec 2028
- trontinemab (RG6102) / Roche
Brainshuttle technology: Focus on trontinemab and newly emerging therapies (118 ABC (Pennsylvania Convention Center)) - Jun 19, 2024 - Abstract #AAIC2024AAIC_2303;
- ||| trontinemab (RG6102) / Roche
Enrollment change: BP42155: Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Apr 22, 2024
P1/2, N=285, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Sep 2027 --> Dec 2028 | Trial primary completion date: Sep 2027 --> Dec 2028 N=210 --> 285
- | gantenerumab (RG1450) / Roche, MorphoSys, trontinemab (RG6102) / Roche
Journal: Delivery of the Brainshuttle (Pubmed Central) - Nov 3, 2023
N=210 --> 285 This study investigates a bispecific modular fusion protein composed of gantenerumab, a fully human monoclonal anti- amyloid-beta (A?) antibody under investigation for AD treatment, with a human transferrin receptor 1-directed Brainshuttle
- ||| trontinemab (RG6102) / Roche
Enrollment change, Trial completion date, Trial primary completion date: BP42155: Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Aug 16, 2023
P1/2, N=210, Recruiting, Sponsor: Hoffmann-La Roche
This study investigates a bispecific modular fusion protein composed of gantenerumab, a fully human monoclonal anti- amyloid-beta (A?) antibody under investigation for AD treatment, with a human transferrin receptor 1-directed Brainshuttle N=120 --> 210 | Trial completion date: Jan 2025 --> Sep 2027 | Trial primary completion date: Jan 2025 --> Sep 2027
- trontinemab (RG6102) / Roche
IMPACT OF CONTINUOUS SITE ENGAGEMENT ON STUDY CONDUCT: INSIGHTS FROM THE "BRAIN SHUTTLE AD" STUDY AND THE CONTINUOUS SCREENING MODEL (EXHIBITION) - Dec 23, 2022 - Abstract #ADPD2023ADPD_1465;
P1/2
Continual site partnership yields mutual benefit to all parties, as demonstrated in this study. Results of a planned survey that aims to validate the impact of this approach will be presented.
- || trontinemab (RG6102) / Roche
Trial completion date, Trial primary completion date: BP42155: Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Dec 2, 2022
P1/2, N=120, Recruiting, Sponsor: Hoffmann-La Roche
Results of a planned survey that aims to validate the impact of this approach will be presented. Trial completion date: Oct 2024 --> Jan 2025 | Trial primary completion date: Oct 2024 --> Jan 2025
- brain shuttle gantenerumab (RG6102) / Roche
Brain Uptake of Brain Shuttle Gantenerumab (RG6102) (Ballroom B) - Apr 24, 2022 - Abstract #PEGS2022PEGS_274;
Brain uptake of therapeutic antibodies has been reported using different experimental systems and diverse methodologies, but the precise measurement of drug levels in all relevant brain compartments is often hampered by technical difficulties. We present the comprehensive characterization of a Brain Shuttle anti-amyloid antibody in Cynomolgus monkeys, including modeling-supported plasma and brain pharmacokinetics, and provide first evidence for brain uptake in humans.
- | brain shuttle gantenerumab (RG6102) / Roche
Journal: Early engagement with the wider patient community in early-phase clinical trial design: Insights from the CareRing caregiver community in designing the Brainshuttle AD trial. (Pubmed Central) - Feb 4, 2022
P1/2
Caregiver support and time commitments go far beyond study visits. The guidance provided by caregivers in the CareRing initiative has helped us adapt the design and holistic management of the Brainshuttle AD trial, and co-create/refine specialized support for both caregivers and participants.
- gantenerumab (RG1450) / Roche, MorphoSys
PK/PD modeling framework to inform the clinical development of RG6102, an amyloid-targeting investigational drug with enhanced brain penetration properties () - Aug 7, 2021 - Abstract #CTAD2021CTAD_62;
P1, P1/2
A PK/PD modeling framework relying on learn-confirm iterations informed the early clinical development trials of RG6102 by combining information across compounds and species. In particular, a model-based approach was valuable to guide first-in-human dosing and inform the design of the first study in healthy volunteers as well as the first study in patients with AD.
- gantenerumab (RG1450) / Roche, MorphoSys
Brainshuttle AD: A Phase Ib/IIa Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6102 in Participants with Prodromal or Mild-to-Moderate Alzheimer’s Disease () - Aug 7, 2021 - Abstract #CTAD2021CTAD_61;
P1/2
Disclosures: HS is a fulltime employee of and owns stock in F. Hoffman-La Roche Ltd. AV is a full-time employee of and owns stock options in F. Hoffman-La Roche Ltd.
- brain shuttle gantenerumab (RG6102) / Roche
[VIRTUAL] EARLY ENGAGEMENT WITH THE WIDER PATIENT COMMUNITY IN EARLY-PHASE CLINICAL TRIAL DESIGN: INSIGHTS FROM THE CARERING CAREGIVER COMMUNITY IN DESIGNING THE BRAINSHUTTLE AD TRIAL () - Aug 2, 2021 - Abstract #AAIC2021AAIC_1110;
P1/2
Caregiver support and time commitments go far beyond study visits. The guidance provided by caregivers in the CareRing initiative has helped us adapt the design and holistic management of the Brainshuttle AD trial, and co-create/refine specialized support for both caregivers and participants.
- gantenerumab (RG1450) / Roche, MorphoSys
[VIRTUAL] Engaging the Alzheimer’s disease (AD) CareRing caregiver community in designing the Phase IB/IIA Brainshuttle AD trial (Room Seville) - May 30, 2021 - Abstract #EAN2021EAN_2031;
P1/2
Early engagement with the broader patient community will help ensure trial designs enable the target population to participate should they wish. Established internal networks can support this type of initiative.
- gantenerumab (RG1450) / Roche, MorphoSys
[VIRTUAL] TRANSLATION OF RG6102, AN AMYLOID-TARGETING THERAPY WITH SUPERIOR BRAIN PENETRATION PROPERTIES, TO THE CLINIC (On Demand Symposia F) - Dec 24, 2020 - Abstract #ADPD2021ADPD_557;
P1
Preliminary first-in-human data revealed a markedly increased CSF/plasma ratio for RG6102 compared with typical mAbs (~0.8% vs. 0.1–0.2%). Studies are underway in individuals with Alzheimer’s disease to test whether these findings translate into an enhanced pharmacodynamic effect (amyloid PET reduction) with the ultimate goal to improve clinical outcomes.
- ||| trontinemab (RG6102) / Roche
Enrollment open: BP42155: Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Dec 19, 2020
P1/2, N=120, Recruiting, Sponsor: Hoffmann-La Roche
Studies are underway in individuals with Alzheimer’s disease to test whether these findings translate into an enhanced pharmacodynamic effect (amyloid PET reduction) with the ultimate goal to improve clinical outcomes. Not yet recruiting --> Recruiting
- |||| trontinemab (RG6102) / Roche
New P1/2 trial: BP42155: Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - Nov 19, 2020
P1/2, N=120, Not yet recruiting, Sponsor: Hoffmann-La Roche
- || trontinemab (RG6102) / Roche
Trial completion: A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants (clinicaltrials.gov) - Aug 13, 2020
P1, N=34, Completed, Sponsor: Hoffmann-La Roche
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- brain shuttle gantenerumab (RG6102) / Roche
[VIRTUAL] Translation of RG6102, an amyloid-targeting therapy Brain Shuttle construct with superior brain penetration properties, to the clinic () - Aug 10, 2020 - Abstract #CTAD2020CTAD_180;
- || trontinemab (RG6102) / Roche
Enrollment change: A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants (clinicaltrials.gov) - Apr 28, 2020
P1, N=34, Active, not recruiting, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed N=60 --> 34
- || trontinemab (RG6102) / Roche
Enrollment closed: A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants (clinicaltrials.gov) - Mar 31, 2020
P1, N=60, Active, not recruiting, Sponsor: Hoffmann-La Roche
N=60 --> 34 Recruiting --> Active, not recruiting
- | trontinemab (RG6102) / Roche
New P1 trial: A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants (clinicaltrials.gov) - Jul 17, 2019
P1, N=60, Recruiting, Sponsor: Hoffmann-La Roche