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Oncology Clinical Trial Finder
Breast Cancer
Location

Active, not recruiting • Phase I, II • Stage III, IV • HER2 positive • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies

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 nivolumab 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 nivolumab to patients with selected advanced malignancies.

Breast Cancer

Study Design
Study type:

Interventional

Estimated enrollment:

390 participant

Actual study start date:

February 24, 2020

Eligibility Criteria
Ages eligible for study:

18 - 999

Sexes eligible for study:

both


Arms and Intervention
  • BDC-1001

  • Nivolumab

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.

  • key

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.

  • other protocol defined inclusion/exclusion criteria may apply.

Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:

Active, not recruiting

Estimated Enrollment:

390

Last Updated:

06/02/2024


Principal Investigator

Bolt Clinical Development


Trial Sponsor

Bolt Biotherapeutics, Inc.

Study Location (35)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Stanford University

Palo Alto, California, United States

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