BDC-1001 +/− Pertuzumab for Breast Cancer

Recruiting at 6 trial locations

Overseen By Joshua Drago, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bolt Biotherapeutics, Inc.

Must not be taking: TLR7/8 agonists

Disqualifiers: Cardiac disease, HIV, Hepatitis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Up to 24 months

11 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, BDC-1001, alone or with pertuzumab, in patients with HER2-positive metastatic breast cancer who didn't respond to previous treatments. The treatment targets and attacks cancer cells by recognizing a specific marker on them. Pertuzumab is an approved treatment for HER2-positive metastatic breast cancer.

Research Team

Bolt Clinical Development

Principal Investigator

Bolt Biotherapeutics

Eligibility Criteria

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

I've had at least 2 treatments targeting HER2, including trastuzumab deruxtecan.

I agree to a biopsy or will provide a past tissue sample if a new biopsy is not possible.

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

Exclusion Criteria

I haven't had TLR7/8 agonist treatment or ISACs in the last year.

I have a history of heart problems or current heart issues.

My brain metastases are stable, without symptoms, and I haven't used steroids in the last 28 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BDC-1001 as a single agent or in combination with pertuzumab for up to 24 months

Up to 24 months

Every 2 weeks (IV administration)

Maintenance

Participants continue receiving BDC-1001 until a criterion for discontinuation is met

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BDC-1001
• Pertuzumab

Trial Overview The study is testing BDC-1001 alone and combined with pertuzumab to assess their effectiveness, safety, tolerability, how the body processes them (PK/PD), and immune response in patients previously treated with trastuzumab deruxtecan for HER2+ metastatic breast cancer.

Participant Groups

Group I: BDC-1001 in Combination With Pertuzumab Experimental Treatment 2 Interventions

BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.

Group II: BDC-1001 Single Agent Experimental Treatment 1 Intervention

BDC-1001 administered intravenously (IV) every 2 weeks

Who Is Running the Clinical Trial?

Bolt Biotherapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

330+

Hoffmann-La Roche

Industry Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

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