BI-1808 as a single agent and with pembrolizumab in treatment of advanced malignancies
Research type
Research Study
Full title
Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First-in-Human, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Malignancies
IRAS ID
1003549
Contact name
Susanne Gertsson
Sponsor organisation
BioInvent International AB
Eudract number
2020-002090-10
Clinicaltrials.gov Identifier
Research summary
This is a multicentre, open-label, Phase 1/2a first-in-human clinical study with to evaluate the safety and tolerability of increasing doses of BI-1808, as a single agent (Phase 1, Part A) and in combination with pembrolizumab (Phase 1, Part B), in participants with advanced malignancies, whose tumours have progressed after standard anti-cancer treatment. Based on the results from the Phase 1 study, the recommended dose of BI-1808 will be selected for the Phase 2 study, which will assess the effect of BI-1808, alone (Phase 2a, Part A) and in combination with pembrolizumab (Phase 2a, Part B), in tissue-specific cohorts.
The duration of the study will be approximately 4 years with an estimated enrolment period of 2.5 years. Screening can take up to 28 days. The initial treatment period will be 8 weeks for all participants. Total duration on treatment will vary by participant depending on whether the participant has experienced clinical benefit. Overall, participants may receive up to 17 doses or receive treatment for up to 1 year from first dose of BI-1808 therapy.
, Pembrolizumab,(PD-1) Immune cells help our body fight infections and are involved in identifying and destroying cancerous cells, but it’s activity is tightly regulated to avoid attack on healthy tissue. This regulatory system is often exploited by cancer cells to escape the immune cell attack. Data shows that a specific receptor called tumour necrosis factor 2 (TNFR2) is highly involved in this regulation. BI-1808 is a fully-human immunoglobulin monoclonal antibody which blocks TNFR2 and targeting this receptor through BI-1808 has the potential to enhance the anti-tumour effect of the immune system.
This study will enrol participants at 15 study sites across the European Union, United Kingdom and Russia . It is planned to recruit up to 60 participants in Phase 1 and Phase 2a each.
Participants will complete study procedures including but not limited to physical exams and ECGs.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0157
Date of REC Opinion
14 Apr 2021
REC opinion
Further Information Favourable Opinion