BDC-1001 + Nivolumab for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called BDC-1001, both alone and with another drug, nivolumab (an immunotherapy), to evaluate its effectiveness on certain types of advanced cancer. The focus is on cancers with high levels of a protein called HER2, which can accelerate cancer growth. Suitable candidates for this trial have a type of solid tumor with HER2 and have exhausted all approved treatments without success. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that BDC-1001, whether used alone or with nivolumab, is generally safe. In earlier studies, patients tolerated BDC-1001 well. Recent safety data recommend a dose of 20 mg/kg every two weeks, indicating that many patients did not experience serious side effects at this dose.
When combined with nivolumab, early studies indicate that BDC-1001 remains well-tolerated. Reports suggest the combination appears safe. Both treatments target cancers expressing HER2, with a focus on avoiding serious harm to patients.
In summary, BDC-1001, alone or with nivolumab, has been studied for side effects. So far, the treatments seem safe for people at the tested doses.12345Why are researchers excited about this trial's treatments?
Researchers are excited about BDC-1001 combined with Nivolumab because it offers a fresh approach to tackling HER2-expressing advanced breast cancer. Unlike standard treatments that often involve chemotherapy or hormone therapy, BDC-1001 is an innovative immune-stimulating antibody conjugate that directly targets tumor cells expressing the HER2 protein. This combination aims to enhance the immune system's response to cancer cells, potentially improving outcomes for patients who might not respond well to existing therapies. Additionally, BDC-1001 is designed to deliver its effects with precision, possibly leading to fewer side effects compared to traditional treatments.
What evidence suggests that this trial's treatments could be effective for breast cancer?
Research has shown promising results for BDC-1001, particularly in early tests where it effectively targeted tumors unresponsive to other HER2 treatments. In human studies, BDC-1001 triggered strong immune responses, increasing certain immune cells that help fight tumors. In this trial, some participants will receive BDC-1001 alone, while others will receive a combination of BDC-1001 and nivolumab. Early research demonstrated that the combination worked even better against HER2-related cancers. This combination aims to enhance the body's ability to target and destroy cancer cells more effectively. Overall, these findings suggest it could be effective for treating advanced HER2-related cancers.12456
Who Is on the Research Team?
Bolt Clinical Development
Principal Investigator
Bolt Biotherapeutics
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors expressing HER2, such as certain breast, colorectal, gastroesophageal, and endometrial cancers. Participants must have tried all other approved treatments without success. They should be relatively healthy (ECOG status 0 or 1) and able to provide tumor tissue for research.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Dose escalation of BDC-1001 as a single agent and in combination with nivolumab to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD)
Expansion
Selected dose administered as monotherapy and in combination with nivolumab to patients with selected advanced malignancies
Maintenance
Subjects continue receiving BDC-1001 until a criterion for discontinuation has been met
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BDC-1001
- Nivolumab
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bolt Biotherapeutics, Inc.
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania