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A First-in-human Study Using BDC-1001 in Advanced HER2-Expressing Solid Tumors

Trial Status: Active

A first-in-human study using BDC-1001 in HER2 expressing advanced malignancies

Inclusion Criteria

  • Patient must have an advanced solid tumor with documented HER2-protein expression or gene amplification for which approved therapies have been exhausted or are not clinically indicated.
  • Measurable disease as determined by RECIST v.1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Tumor tissue (archival or collected prior to the study start) available for exploratory biomarker evaluation.

Exclusion Criteria

  • History of severe hypersensitivity to any ingredient of the study drug(s), including trastuzumab or other monoclonal antibody.
  • Previous treatment with a TLR 7, TLR 8 or a TLR 7/8 agonist.
  • Impaired cardiac function or history of clinically significant cardiac disease
  • Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
  • Active SARS-CoV-2 infection
  • Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Bob T. Li
Phone: 646-888-4201
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

This study has four parts. Part 1 is a dose escalation of BDC-1001 as a single agent to

determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum

protocol dose (MPD) recommended for Part 3. In Part 3, the selected dose will be administered

as monotherapy to patients with selected advanced malignancies. Part 2 is a dose escalation

of BDC-1001 in combination with pembrolizumab to determine the maximum tolerated dose (MTD),

recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD) recommended for Part 4. In

Part 4, the selected dose will be administered in combination with pembrolizumab to patients

with selected advanced malignancies.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Bolt Biotherapeutics, Inc.

  • Primary ID BBI-20201001
  • Secondary IDs NCI-2020-03932
  • Clinicaltrials.gov ID NCT04278144