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Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT05954143
Recruitment Status : Recruiting
First Posted : July 20, 2023
Last Update Posted : February 15, 2024
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Bolt Biotherapeutics, Inc.

Study Description
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Brief Summary:
This is an open-label, Phase 2 study to evaluate preliminary anti-tumor activity, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BDC-1001 administered as a single agent and in combination with pertuzumab in subjects with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan (Enhertu®).

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer HER2-positive Breast Cancer Drug: BDC-1001 Drug: Pertuzumab Phase 2

Detailed Description:
Eligible subjects will be randomly assigned in a 1:1 ratio to receive BDC-1001 as a single agent or BDC-1001 in combination with pertuzumab. Within each treatment arm, a Simon 2-stage design will be applied. Subjects will receive study treatment (i.e., BDC-1001 or BDC-1001 in combination with pertuzumab) for up to 24 months after Cycle 1 Day 1 (C1D1), until disease progression, unacceptable toxicity, or withdrawal for any reason.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2, Multi-Center, Randomized, Open-Label Trial of BDC-1001 as a Single Agent and in Combination With Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab Deruxtecan
Actual Study Start Date : November 30, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Pertuzumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: BDC-1001 Single Agent
BDC-1001 administered intravenously (IV) every 2 weeks
 Drug: BDC-1001
BDC-1001 is an immune-stimulating antibody conjugate (ISAC) designed to be delivered systemically (intravenously) and act locally by targeting HER2-expressing tumors and related metastatic disease for destruction by the innate and adaptive immune systems. BDC-1001 consists of an investigational biosimilar of the humanized monoclonal antibody (mAb) trastuzumab that is chemically conjugated to a toll-like receptor (TLR)7/8 agonist (payload) with an intervening non-cleavable, cell membrane impermeable linker.
Experimental: BDC-1001 in Combination With Pertuzumab
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.
 Drug: BDC-1001
BDC-1001 is an immune-stimulating antibody conjugate (ISAC) designed to be delivered systemically (intravenously) and act locally by targeting HER2-expressing tumors and related metastatic disease for destruction by the innate and adaptive immune systems. BDC-1001 consists of an investigational biosimilar of the humanized monoclonal antibody (mAb) trastuzumab that is chemically conjugated to a toll-like receptor (TLR)7/8 agonist (payload) with an intervening non-cleavable, cell membrane impermeable linker.

Drug: Pertuzumab
Pertuzumab is a monoclonal antibody that targets HER2 and prevents dimerization of HER2 with other members of the HER family (HER1, HER3, and HER4), thereby blocking ligand-activated downstream signaling.
Other Name: Perjeta®


Outcome Measures
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Primary Outcome Measures :
  1. Anti-tumor activity of BDC-1001 as a single agent and in combination with pertuzumab [ Time Frame: 12 weeks ]
    Objective Response Rate (ORR) according to RECIST v1.1


Secondary Outcome Measures :
  1. Anti-tumor activity of BDC-1001 as a single agent and in combination with pertuzumab [ Time Frame: Up to 24 months ]
    Duration of Response (DOR)

  2. Anti-tumor activity of BDC-1001 as a single agent and in combination with pertuzumab [ Time Frame: Up to 24 months ]
    Disease Control Rate (DCR)

  3. Anti-tumor activity of BDC-1001 as a single agent and in combination with pertuzumab [ Time Frame: Up to 24 months ]
    Progression-Free Survival (PFS)

  4. Anti-tumor activity of BDC-1001 as a single agent and in combination with pertuzumab [ Time Frame: Up to 24 months ]
    Overall Survival (OS)

  5. Incidence of treatment-emergent events with BDC-1001 as a single agent and in combination with pertuzumab [ Time Frame: Up to 24 months ]
    Treatment-emergent Adverse Events (TEAEs)

  6. Incidence of treatment-emergent events with BDC-1001 as a single agent and in combination with pertuzumab [ Time Frame: Up to 24 months ]
    Treatment-emergent Serious Adverse Events (TESAEs)

  7. Exposure profile of BDC-1001 as a single agent and in combination with pertuzumab [ Time Frame: Up to 24 months ]
    Trough serum concentration (Cmin)

  8. Exposure profile of BDC-1001 as a single agent and in combination with pertuzumab [ Time Frame: Up to 24 months ]
    Peak serum concentration (Cmax)

  9. Immunogenicity of BDC-1001 as a single agent and in combination with pertuzumab [ Time Frame: Up to 24 months ]
    Incidence of anti-BDC-1001 antibody (ADAs)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the breast that is HER2+ (IHC 3+ or gene amplification by ISH or NGS).
  • Have received 2 or more prior lines of anti-HER2-directed therapies, at least 1 in the metastatic setting and including trastuzumab deruxtecan.
  • Measurable disease as determined by RECIST v.1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Have life expectancy of greater than 12 weeks per the Investigator.
  • All subjects must agree to have a biopsy prior to enrollment. If, in the judgment of the Investigator, a biopsy is not safely accessible or clinically feasible an archival tumor tissue sample must be submitted in lieu of a freshly collected specimen.

Key Exclusion Criteria:

  • History of severe hypersensitivity to any ingredient of BDC-1001 or pertuzumab.
  • Previous treatment with a small molecule TLR7/8 agonist or TLR7/8 agonist that has been conjugated to tumor-targeting antibody such as ISACs within 12 months before starting study treatment.
  • Impaired cardiac function or history of clinically significant cardiac disease.
  • Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
  • Central nervous system metastases with the exception of disease that is asymptomatic, clinically stable, and has not required steroids for at least 28 days before starting study treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05954143


Contacts
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Contact: Bolt Biotherapeutics 1-650-434-8640 clinicaltrials@boltbio.com

Locations
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United States, California
City of Hope Recruiting
Irvine, California, United States, 92618
Contact: Irene Kang, MD    877-467-3411    ikang@coh.org   
Principal Investigator: Irene Kang, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Joshua Drago, MD    646-888-6971    dragoj@mskcc.org   
Principal Investigator: Joshua Drago, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kalli Cannon, RN, BSN    405-271-8001 ext 48686    kalli-cannon@ouhsc.edu   
Principal Investigator: Wajeeha Razaq, MD         
United States, Virginia
Virginia Cancer Specialists Recruiting
Arlington, Virginia, United States, 22205
Contact: Carrie Friedman, RN, BSN, OCN    703-636-1473    carrie.friedman@usoncology.com   
Principal Investigator: Isabelle Le, MD         
Sponsors and Collaborators
Bolt Biotherapeutics, Inc.
Hoffmann-La Roche
Investigators
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Study Director: Bolt Clinical Development Bolt Biotherapeutics
More Information
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Responsible Party: Bolt Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05954143    
Other Study ID Numbers: BBI-20231001
First Posted: July 20, 2023    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents