BDC-1001 + Nivolumab 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, alone and with another drug, in patients with advanced HER2-positive cancers. BDC-1001 aims to attack cancer cells directly, and the other drug boosts the immune system to fight the cancer.
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