Trial | NCT04278144  Report issue

Title

A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    390
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.
Study Started
Feb 24
2020
Primary Completion
Jan 31
2025
Anticipated
Study Completion
Oct 31
2026
Anticipated
Last Update
Sep 13
2023

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

Single agent BDC-1001 Experimental

Escalating doses followed by expansion targeting HER2-expressing advanced malignancies

Combination BDC-1001 plus nivolumab Experimental

Escalating doses followed by expansion targeting HER2-expressing advanced malignancies

Criteria 

Key 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.
No Results Posted