BDC-1001 +/− Pertuzumab for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, BDC-1001, both alone and with pertuzumab (also known as Perjeta), to evaluate their effectiveness against HER2-positive breast cancer. Researchers aim to determine if these treatments can shrink tumors and assess their safety and tolerability. The study seeks participants with HER2-positive metastatic breast cancer who have previously tried at least two other treatments, including trastuzumab deruxtecan. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in cancer treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BDC-1001, both alone and with pertuzumab, generally appears safe for people. In earlier studies, participants tolerated BDC-1001 well, even at different doses, with no major side effects reported, indicating good safety. When combined with pertuzumab, BDC-1001 was also well-tolerated. Initial results demonstrated that participants handled the combination well at various doses. So far, the safety data appears promising for those considering joining the trial.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about BDC-1001 for breast cancer because it offers a fresh approach compared to traditional treatments like chemotherapy or hormone therapy. BDC-1001 is designed to enhance the immune system's response against cancer cells by targeting them directly, potentially leading to more effective and precise treatment. Additionally, when combined with Pertuzumab, a monoclonal antibody that disrupts cancer cell growth, it may offer a synergistic effect that could improve outcomes for patients. This combination has the potential to target cancer cells more aggressively and with greater precision than existing therapies.
What evidence suggests that this trial's treatments could be effective for HER2+ metastatic breast cancer?
Research has shown that BDC-1001, one of the treatments studied in this trial, shows promise in fighting tumors unresponsive to current anti-HER2 treatments. Early studies demonstrated its effectiveness in reducing tumor size by activating the immune system. In this trial, some participants will receive BDC-1001 alone, while others will receive it in combination with pertuzumab, a drug already used for breast cancer. Lab studies found the combination well-tolerated and potentially effective against tumors. Initial findings suggest that BDC-1001, alone or with pertuzumab, could benefit people with HER2-positive metastatic breast cancer, especially those who have tried other treatments like trastuzumab deruxtecan. Overall, the evidence supports BDC-1001 as a promising new option for treating difficult breast cancers.12356
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 individuals with HER2-positive metastatic breast cancer who have tried at least two anti-HER2 therapies, including trastuzumab deruxtecan. Participants should be in good physical condition (ECOG 0 or 1), have measurable disease, and a life expectancy over 12 weeks. They must agree to a biopsy or provide an archival tissue sample if needed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BDC-1001 as a single agent or in combination with pertuzumab for up to 24 months
Maintenance
Participants continue receiving BDC-1001 until a criterion for discontinuation is met
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BDC-1001
- Pertuzumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bolt Biotherapeutics, Inc.
Lead Sponsor
Hoffmann-La Roche
Industry Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University