BDC-1001 + Nivolumab for Breast Cancer

Recruiting at30 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Bolt Biotherapeutics, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

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.

Research Team

Bolt Clinical Development

Principal Investigator

Bolt Biotherapeutics

Eligibility Criteria

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

I have tumor tissue samples available for research.

Measurable disease as determined by RECIST v.1.1

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I currently have COVID-19.

I have not received treatment for tumors or cancer spread to my brain or spinal cord.

I have HIV, active hepatitis B, or hepatitis C.

Treatment Details

Interventions

• BDC-1001 (Monoclonal Antibodies)
• Nivolumab (Monoclonal Antibodies)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview The study is testing BDC-1001 alone and combined with Nivolumab in patients whose tumors overexpress the HER2 protein or gene. It's a first-in-human trial aiming to find out how safe these treatments are and how well they work against different types of cancer.

Participant Groups

Group I: Single agent BDC-1001 Experimental Treatment 1 Intervention

Escalating doses followed by expansion targeting HER2-expressing advanced malignancies

Group II: Combination BDC-1001 plus nivolumab Experimental Treatment 2 Interventions

Escalating doses followed by expansion targeting HER2-expressing advanced malignancies

Who Is Running the Clinical Trial?

Bolt Biotherapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

330+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

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