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Study on BI-1808 and Pembrolizumab for Patients with Advanced Solid Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for advanced solid tumors, which are types of cancer that have spread beyond their original location. The study involves two medications: BI-1808 and pembrolizumab. BI-1808 is a new treatment being tested, and it is a type of medication known as a monoclonal antibody, which is designed to target specific proteins in the body. Pembrolizumab, also known by its brand name KEYTRUDA, is an existing cancer treatment that helps the immune system fight cancer cells.

The purpose of the study is to evaluate the safety and tolerability of BI-1808 when used alone and in combination with pembrolizumab. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will be conducted in phases, starting with testing BI-1808 by itself and then in combination with pembrolizumab. Researchers aim to find the most suitable dose that can be safely given to patients.

Throughout the study, participants will be monitored for any side effects or adverse reactions to the treatments. The study will also look at how the body processes BI-1808 and how it interacts with the immune system. This research is important for understanding how these treatments can be used to help people with advanced cancers and to determine the best way to use them in future treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    A biopsy may be required to obtain a sample of the tumor tissue, unless a previous sample is available and meets the study criteria.

  2. Step 2

    Phase 1, part a: single agent treatment

    The first phase involves receiving BI-1808 as a single agent. This is administered through an intravenous (IV) infusion.

    The dosage of BI-1808 is gradually increased to assess safety and tolerability. Monitoring for any adverse effects is conducted throughout this phase.

  3. Step 3

    Phase 1, part b: combination treatment

    In this phase, BI-1808 is combined with pembrolizumab (also known as KEYTRUDA). Both are administered via IV infusion.

    The combination aims to evaluate the safety and identify any dose-limiting toxicities. The goal is to determine the maximum tolerated dose.

  4. Step 4

    Phase 2a: recommended dose selection

    Based on the findings from Phase 1, a recommended dose for Phase 2 is selected.

    Participants continue to receive the treatment at this dose to further assess its effects on advanced malignancies.

  5. Step 5

    Ongoing monitoring and follow-up

    Throughout the trial, regular monitoring of health status and any side effects is conducted.

    Follow-up visits are scheduled to ensure the safety and effectiveness of the treatment.

Who can join the trial?

9 criteria

  • The patient must be willing and able to provide written permission to participate in the trial.
  • The patient must be at least 18 years old on the day they sign the permission form.
  • The patient must have a confirmed diagnosis of an advanced malignancy, which means a type of cancer that has spread or is not easily treatable.
  • The patient must have already received standard treatment for their condition, or be unable to tolerate it, refuse it, or not be eligible for it.
  • The patient must have at least one measurable area of disease, as defined by a specific set of guidelines called RECIST v 1.1.
  • The patient must be willing to safely undergo tissue biopsies, which are small samples taken from the affected area, if needed. If the doctor thinks it is not safe or possible, the biopsy is not required. A previous sample from a standard care biopsy can be used if it was taken after the last treatment and before joining the study.
  • The patient must have a life expectancy of at least 12 weeks.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which is a scale used to assess how well a patient can perform daily activities.
  • The patient must have adequate organ function, which will be confirmed by lab tests.

Who cannot join the trial?

5 criteria

  • Patients who do not have advanced solid tumors cannot participate. Advanced solid tumors are a type of cancer that has spread and formed solid masses in the body.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not able to receive an intravenous (IV) infusion cannot participate. An IV infusion is a way to deliver medicine directly into the bloodstream through a vein.
  • Patients who are not able to tolerate the study medication or its combination with pembrolizumab cannot participate. Pembrolizumab is a medication used to help the immune system fight cancer.
  • Patients who are part of a vulnerable population, such as those with certain health conditions or disabilities, may not be eligible to participate.
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Investigated drugs

  • BI-1808

    is a monoclonal antibody designed to target and block the activity of a specific protein known as Tumor Necrosis Factor Receptor 2 (TNFR2). This protein is involved in the growth and survival of cancer cells. By inhibiting TNFR2, BI-1808 aims to slow down or stop the progression of advanced cancers. In this trial, BI-1808 is being tested both as a standalone treatment and in combination with another medication to evaluate its safety and effectiveness.

  • Pembrolizumab

    is a type of cancer treatment known as an immune checkpoint inhibitor. It works by helping the immune system recognize and attack cancer cells more effectively. Pembrolizumab blocks a specific protein on the surface of immune cells, which can enhance the body's natural defense against cancer. In this trial, pembrolizumab is used in combination with BI-1808 to assess whether the combination can improve treatment outcomes for patients with advanced cancers.

What is already known about the treatment

BI-1808 – This medication is administered through intravenous infusion and is currently being studied in clinical trials for its safety and effectiveness. It is primarily being investigated for use in patients with advanced solid tumors. BI-1808 is a monoclonal antibody that targets the Tumor Necrosis Factor Receptor 2 (TNFR2), which plays a role in regulating immune responses and tumor growth. It is classified as an immunotherapy agent, and its mechanism involves blocking TNFR2 to potentially enhance the body's immune response against cancer cells.

Investigated diseases

Advanced Solid Tumors – These are a group of cancers that originate in solid organs or tissues, such as the breast, lung, or colon, and have progressed to an advanced stage. At this stage, the tumors have typically spread beyond their original location to other parts of the body, making them more challenging to treat. The progression of advanced solid tumors often involves the growth of the primary tumor and the development of metastases, which are secondary cancerous growths. As the disease advances, it can affect the function of the organs involved and may lead to various symptoms depending on the location and size of the tumors. The behavior and progression of these tumors can vary widely depending on the type of cancer and individual patient factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-509847-29-00Protocol code19-BI-1808-01Estimated enrolment364 patientsSponsorBioInvent International AB

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