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Study of BDC-1001 and Nivolumab for Patients with Advanced HER2-Positive Solid Tumors

Verified siteRegistered drugNo placebo
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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 patients with advanced HER2-expressing solid tumors. These are types of cancer that have a protein called HER2 on their surface, which can make the cancer grow more quickly. The study is testing a new treatment called BDC-1001, both on its own and in combination with another medication called nivolumab, which is also known by its code names BMS936558 and ABP 206. Nivolumab is a type of drug that helps the immune system fight cancer.

The purpose of the study is to find out how safe and tolerable BDC-1001 is when used alone and when combined with nivolumab. The study will also look at how well these treatments work against the cancer. The study is divided into different parts. In the first part, patients will receive BDC-1001 alone to see how their bodies react to it. In the second part, patients will receive both BDC-1001 and nivolumab to see if the combination is safe and effective. Later parts of the study will focus on how well the treatments work in shrinking the tumors or stopping them from growing.

Participants in the study will receive the treatments through an infusion, which means the medication is given directly into the bloodstream through a vein. The study will monitor patients closely to check for any side effects and to see how the cancer responds to the treatment. The goal is to find the best dose of BDC-1001 that can be used safely and effectively, both on its own and with nivolumab, for treating advanced HER2-expressing solid tumors.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The study begins with the administration of BDC-1001 as a single agent. This medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

    The purpose of this phase is to assess the safety and tolerability of BDC-1001 in patients with advanced HER2-expressing solid tumors. The dosage will be adjusted to determine the most appropriate level for further study.

  2. Step 2

    Combination treatment phase

    Following the initial phase, BDC-1001 is administered in combination with nivolumab. Nivolumab is also given as an intravenous infusion.

    This phase aims to evaluate the safety and tolerability of the combination treatment. The goal is to find the recommended dose for further study.

  3. Step 3

    Dose expansion phase

    In this phase, the study expands to include more patients to further evaluate the antitumor activity of BDC-1001 alone and in combination with nivolumab.

    The focus is on understanding how effective the treatment is in reducing tumor size or slowing its growth in patients with advanced HER2-positive solid tumors.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the patient's response to the treatment and to identify any side effects.

    Patients are required to provide blood samples and undergo imaging tests to evaluate the treatment's impact on the tumor.

Who can join the trial?

14 criteria

  • The patient must have an advanced solid tumor, which means a severe form of cancer that has spread, for which there are no more approved treatments available, or the patient cannot tolerate or is not eligible for other treatments.
  • The tumor must show **HER2 expression**, which means the cancer cells have a protein called HER2 on their surface. This includes both low and high levels of HER2.
  • The patient must be willing and able to provide blood samples before starting the study.
  • The patient must be at least 4 weeks recovered from any major surgery.
  • The patient's laboratory test results at the start of the study must meet the study's requirements.
  • Women who can have children must use a **highly effective contraceptive method**, which is a method that has less than a 1% chance of failing each year, during the study and for 7 months after the treatment ends.
  • Men who can father children and have partners who can become pregnant must use condoms along with another highly effective contraceptive method during the study and for 7 months after the treatment ends. Men are considered potent unless they have been surgically sterilized.
  • The patient must be 18 years old or older.
  • The patient must be mentally competent, meaning they can understand and sign the consent form.
  • The patient must have an **Eastern Cooperative Oncology Group performance status** of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
  • The patient must have a life expectancy of more than 12 weeks, as determined by the doctor.
  • The patient must have a **left ventricular ejection fraction (LVEF)** of 50% or higher, which is a measure of how well the heart is pumping, checked by a heart ultrasound or a special scan within 28 days before starting the study.
  • The disease must be measurable by a specific set of criteria called **Response Evaluation Criteria in Solid Tumors (RECIST) v1.1**, which is a way to measure how the tumor responds to treatment.
  • For Parts 1 and 2, the patient must be able to provide a sample of their tumor tissue, either from a previous surgery or a new biopsy, for research purposes. If a tissue block is not available, at least 15 unstained slides may be submitted. For Parts 3 and 4, a new biopsy should be done, and fresh tissue submitted. If a new biopsy is not possible, an old tumor tissue sample must be provided.

Who cannot join the trial?

10 criteria

  • Patients who have not been diagnosed with advanced HER2-expressing solid tumors. This means the cancer cells have a high level of a protein called HER2 on their surface.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to safely receive the study treatment due to other health conditions.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent major surgery or are recovering from a major surgery.
  • Patients who have a history of severe allergic reactions to similar treatments.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of another type of cancer that might interfere with the study results.
  • Patients who have a condition that affects their ability to understand or follow the study instructions.
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Investigated drugs

  • BDC-1001

    is an experimental medication being studied for its potential to treat advanced solid tumors that express a protein called HER2. The study aims to understand how safe and tolerable BDC-1001 is when used alone and to find the best dose for treatment. Researchers are also looking at how well BDC-1001 works against tumors.

  • Nivolumab

    is a medication that helps the immune system fight cancer. It is being tested in combination with BDC-1001 to see if it can enhance the treatment's effectiveness against advanced HER2-expressing solid tumors. The study is examining the safety and potential benefits of using these two medications together.

What is already known about the treatment

BDC-1001 – BDC-1001 is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced HER2-expressing solid tumors. It is in the early phases of clinical research, focusing on its safety, tolerability, and preliminary antitumor activity. The main therapeutic indication is for patients with advanced cancers that express the HER2 protein. BDC-1001 works by targeting the HER2 protein on cancer cells, potentially enhancing the immune system's ability to attack these cells. It is classified as an investigational immunotherapy agent.

Investigated diseases

Advanced HER2-Expressing Solid Tumors – These are a group of cancers characterized by the overexpression of the HER2 protein on the surface of cancer cells. This overexpression can lead to more aggressive tumor growth and spread. HER2-expressing tumors can occur in various organs, including the breast, stomach, and others. The progression of these tumors often involves rapid cell division and the potential to invade nearby tissues or spread to other parts of the body. The presence of HER2 can influence the behavior of the tumor and its response to certain therapies. Understanding the role of HER2 is crucial in managing and studying these types of cancers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-518411-19-00Protocol codeBBI-20201001Estimated enrolment332 patientsSponsorBolt Biotherapeutics Inc.

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