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

Purpose

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

Conditions

  • HER2-positive Solid Tumors
  • HER2-positive Breast Cancer
  • HER2-positive Colorectal Cancer
  • HER2-positive Gastroesophageal Cancer
  • HER2-positive Endometrial Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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. Other protocol defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Multiple ascending dose and dose-expansion of BDC-1001 administered as a single agent or in combination with nivolumab.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single agent BDC-1001 		Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
  • Drug: BDC-1001
    Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
Experimental
Combination BDC-1001 plus nivolumab 		Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
  • Drug: BDC-1001
    Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
  • Drug: Nivolumab
    Programmed death receptor-1 (PD 1)-blocking antibody
    Other names:
    • Opdivo

Recruiting Locations

Georgetown University Medical Center
Washington, District of Columbia 20007
Contact:
Stephanie Wagner, RN
202-687-9782
sw1095@georgetown.edu

More Details

Status
Recruiting
Sponsor
Bolt Biotherapeutics, Inc.

Study Contact

Bolt Biotherapeutics
+1 650 434 8640
clinicaltrials@boltbio.com

Detailed Description

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.