BDC-1001 + Nivolumab for Breast Cancer

Recruiting at 30 trial locations

Overseen By Bolt Biotherapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bolt Biotherapeutics, Inc.

Must not be taking: TLR agonists, Monoclonal antibodies

Disqualifiers: Cardiac disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

175 Participants Needed

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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)

up to 21 days

Expansion

Selected dose administered as monotherapy and in combination with nivolumab to patients with selected advanced malignancies

2 years

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

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BDC-1001
• Nivolumab
• Pembrolizumab

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.

How Is the Trial Designed?

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