Study of BI-1808 with or without Pembrolizumab for Advanced Cancers
This study is testing a new drug called BI-1808, both alone and in combination with Pembrolizumab (KEYTRUDA®), for people with advanced cancers like ovarian cancer or T-cell lymphoma. The main goals are to see how safe BI-1808 is, what side effects it might cause, and to find the best dose for future studies. Participants will receive BI-1808, or BI-1808 with Pembrolizumab, through an IV (intravenous) infusion every three weeks. This study is for adults aged 18 and older who have advanced cancer that has continued to grow after standard treatments. The study aims to enroll 176 participants.
- Study design
- This is a Phase 1/2a study, which means it's an early-stage trial looking at safety and dosage, and then expanding to see how well the treatment works. It is an open-label study, meaning both you and your doctors will know which treatment you are receiving.
- What's involved
- Participants will receive IV infusions of BI-1808 alone or in combination with Pembrolizumab every 3 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for adverse events for up to 2 years and 90 days after starting treatment, and for serious adverse events for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
At a glance
Conditions
Where it's being run
25 sites across 9 statesStudy leadership
- Andres McAllister, PhD · STUDY_DIRECTOR · BioInvent International AB
Who to contact
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What this trial measures
- Occurrence of adverse events (AEs)From the start of the study treatment for up to 2 years and 90 days.
AEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between AEs and the exposure to the study treatment.
- Identify DLTs, determine the maximum tolerated dose and select a recommended Phase 2 dose (RP2D) of BI-1808, given via intravenous (IV) infusion, as a single agent (Phase 1, Part A), and in combination with pembrolizumab (Phase 1, Part B)Up to 104 weeks (2 years)
Select the RP2D dose for BI-1808ing mTPI-2 design.
- Occurrence of serious adverse events (SAEs)Up to 104 weeks (2 years)
SAEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between SAEs and the exposure to the study treatment